Medical device design jobs in Rochester, New YorkCreate job alerts

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects; and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be Hybrid in any global QuidelOrtho site. * Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. * Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality. * Ability to manage complaint trending activities and related software system validations * Ability to compile and present quality data and analysis to the business eg: Management Review. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. * 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. * Proven ability to lead and develop high-performing teams and build future technical and people leaders * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. • Excellent collaboration, influence, and communication skills across functional and organizational boundaries., • Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement., • Experience leading in a matrixed, global organization and managing competing priorities effectively., • Commitment to scientific integrity, compliance excellence, and continuous improvement. Preferred: * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. * Experience supporting or leading Health Authority or Notified Body inspections. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Software Engineer - (Database and Applications) to join our R&D Instrument Platforms organization and provide technical leadership in developing features and applications within our portfolio of products while having a primary focus on database schema design and implementation. This is an opportunity to shape core architecture and influence the development of safety-critical systems. Responsibilities span the full lifecycle, including requirements, design, implementation, and testing of database and middleware components. This position is onsite in Rochester, NY. Note: This position is not currently eligible for visa sponsorship. The Responsibilities • Design and implement modular middleware components for Linux-based device software systems using modern C++ (C++20/23)., • Architect and implement relational database schema and ensure data integrity across distributed systems., • Act as Software SME in design discussions with Product, • Managers and Systems Engineers to define requirements., • Define system architecture and development processes to ensure long-term maintainability and traceability within a regulated quality management system., • Conduct feasibility analysis and develop proof-of-concepts for middleware solutions., • Contribute to system-wide synchronization, logging, and monitoring infrastructure for observability., • Enforce memory-safe design practices throughout requirement gathering, architecture definition, unit testing, and code reviews., • Develop integration test frameworks for multi-process Linux environments, • Perform other work-related duties as assigned. The Individual Required: • B.S. or M.S. Degree in Computer Science, Computer Engineering or a related discipline required., • Minimum of 5 years required with bachelor's or 3 years with master's degree, preferably leading in a medical device environment or equivalent combination of education and experience., • Expertise in relational database schema design and implementation (PostgreSQL preferred)., • Performance tuning: query optimization, indexing strategies, and capacity planning, • Database migration and version control, • Backup, recovery, and disaster recovery planning, • Proficiency in Modern C++ (C++11 minimum, C++20 or newer preferred) with a strong understanding of memory management thread-safety, this is not a web or front-end development position., • Familiarity with Agile development practices and toolchains, including Git, CI/CD integration, and issue tracking platforms such as Jira, GitHub, or Azure DevOps., • Strong analytical and debugging skills with a systematic approach to solving complex technical issues. Ability to travel 5% or less, domestically. Preferred: • Embedded systems development, including Linux or RTOS., • Design and integration of modular, maintainable software interfaces using Interface Definition Languages (IDLs), versioned APIs (e.g., REST), event-driven or pub/sub architectures, and schema validation (e.g., JSON Schema, XSD) to support cross-language and backend-to-UI interoperability., • Experience or working knowledge of the Rust programming language., • Familiarity with scripting languages such as Python and Bash for automation and tooling., • Proficiency in modern cross-platform software design using contemporary build systems (e.g., CMake, etc.)., • Designing testable architectures and developing deterministic test cases using automated testing frameworks, including mocking, emulation, and simulation tools for Linux-based device software systems. The Key Working Relationships Internal Partners: • Software development partners and suppliers. The Work Environment This role is based at our beautiful waterfront campus with walking trail, fitness center, and full-service onsite cafeteria in the Rochester, NY region. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. Up to 60% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines Physical Demands Must be able to work at desk, standing or sitting for extended periods of time. Other physical demands include bending, kneeling, talking, hearing, and vision. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $100,000 to $120,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-TO1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role QuidelOrtho is looking for a Senior Software Engineer, Linux C++ to join our R&D Instrument Platforms organization to provide technical leadership for the realization of a new / substantially evolved existing product / feature within our portfolio of products. This position is responsible for developing software and supporting software development processes and tools. This includes, but is not limited to, requirements development, design, build, implementation, and testing. This role focuses on designing and implementing robust inter-process and inter-node communication for distributed embedded Linux systems. Emphasis will be placed on real-time messaging, safety, and scalability to support time-sensitive workflows across multiple software components and hardware nodes. This position is onsite full-time located in Rochester, NY. The Responsibilities • Design and implement modular middleware components that enable real-time communication between distributed subsystems using DDS, ROS2, or other inter-process communication (IPC) mechanisms., • Act as Software SME in design discussions with Product Managers and Systems Engineers to define requirements., • Help define system architecture, configurations, and development processes to ensure long-term maintainability and traceability within a regulated quality management system., • Design and implement service abstraction layers to decouple application logic from hardware and OS dependencies., • Determines technical / operational feasibility by conducting system analysis, developing POCs, etc., • Contribute to system-wide synchronization, logging, and monitoring infrastructure to support observability of system performance, resource utilization, and health., • Enforce good software design practices throughout requirement gathering, architecture definition, unit testing, and code reviews., • Develop integration test frameworks to ensure robustness in multi-process embedded environments., • Perform other work-related duties as assigned. The Individual Required: • This position is not currently eligible for visa sponsorship., • B.S. or M.S. Degree in Computer Science, Computer Engineering or a related discipline required., • Proficiency in Modern C++ (C++11 minimum, C++17 or newer preferred) with a strong focus on memory-safe design techniques., • Experience with IPC messaging middleware such as DDS, protobuf, ZeroMQ, etc., • Familiarity with Agile development practices and toolchains, including Git, CI/CD integration, and issue tracking platforms such as Jira, GitHub, or Azure DevOps., • Experience developing and testing embedded system software for real time applications/robotic systems., • Strong analytical and debugging skills with a systematic approach to solving complex technical issues., • Experience with automated testing frameworks such as GTest, PyTest, or similar, including test mocking, emulation, and simulation tools for embedded Linux systems., • Ability to travel 5% or less, domestically. Preferred Skills: • Embedded systems development, including RTOS and real-time applications., • Design and integration of modular, maintainable software interfaces using Interface Definition Languages (IDLs), versioned APIs (e.g., REST), event-driven or pub/sub architectures, and schema validation (e.g., JSON Schema, XSD) to support cross-language and backend-to-UI interoperability., • Experience or working knowledge of the Rust programming language., • Familiarity with scripting languages such as Python and Bash for automation and tooling., • Proficiency in modern cross-platform software design using contemporary build systems (e.g., CMake, etc.)., • Designing testable architectures and developing deterministic test cases using automated testing frameworks, including mocking, emulation, and simulation tools for embedded Linux systems., • Familiarity with USB, Ethernet, and CAN communication protocols. The Key Working Relationships Internal Partners: • Systems Engineers, Hardware Engineers, Quality/Regulatory, Operations, Marketing, Manufacturing, Service, Clinical Medical Affairs, Project Management Office External Partners: • Software Development partners and suppliers. The Work Environment The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Including walk-in fridges/freezer. Up to 60% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines Physical Demands A job description should include physical demands that are essential to the job's performance to comply with the American with Disabilities Act (ADA).Physical demands arethe level and duration of physical exertion needed to perform critical tasks, such as: sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling.Other physical demands include: • Bending, • Crawling, • Stooping, • Vision, • Climbing or balancing, • Kneeling, • Crouching, • Talking or hearing, • Tasting or smelling Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $100,000 to $120,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Staff Systems Engineer for in vitro diagnostic instrument development who will provide technical leadership and contribution to product design for QuidelOrtho's instrument platforms. Our Staff System Engineers have extensive experience and expertise in the field of systems engineering. They possess in-depth knowledge of systems engineering principles, processes, tools, and are often involved in high-level planning, integration, and optimization of complex systems. This role requires advanced problem-solving skills, the ability to lead a smaller team on large-scale projects, and a commitment to ongoing professional development. Additional responsibilities may include management of large technical projects or processes that span outside the immediate job area. Work is performed with limited oversight. This position is onsite full-time in Rochester, NY. Note: This position is not currently eligible for visa sponsorship. The Responsibilities • Gather, analyze, and manage system requirements, ensuring alignment with regulatory standards and customer needs, • Conduct risk analysis and mitigation strategies, including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA)., • Lead formal design reviews; provide system-level perspective and ensure compliance with design controls., • Drive instrument development by creating a plan of execution using knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project., • Utilize modeling, simulation, and data analytics to assess system behavior and optimize design performance., • Diagnose and resolve system-level issues, ensuring timely delivery of solutions. Use system engineering tools to carry out Root Cause Investigations and determine corrective and preventative action plans., • Provide status updates as needed to senior leadership, highlighting progress, risks, and mitigation plans., • Responsible for making moderate to significant improvements of processes, systems or products to enhance performance of technical job area., • Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices., • Develop and execute system level test plans and protocols to validate system performance, reliability growth, and safety., • Conduct statistical analysis to determine appropriate sample sizes for verification and validation activities, ensuring robust and reliable results., • Collaborate with key stakeholders and external design partners to deliver product features that improve our customer experience, product performance and safety., • Perform other work-related duties as assigned. The Individual Required: • Bachelor's Degree in System Engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience is required, master's degree preferred., • Minimum 8+ years relevant experience required with a track record of delivering products in the medical, automotive, and/or defense industries, preferably with relevant medical device design exposure., • Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement, • Demonstrated experience in applying statistical techniques to real-world problems, particularly in the medical device industry., • Demonstrated experience in systems engineering tools and methodologies, as well as experience with software development, hardware design, reliability growth testing and systems integration., • Strong verbal and written communication skills, with the ability to convey complex technical information to diverse audiences., • Ability to work effectively in a collaborative, cross-functional team environment. Including the mentoring of more junior engineers., • Strong analytical and problem-solving skills, with a focus on delivering innovative solutions., • Must have strong customer focus to ensure that the experience delivered by the product is consistent with expectations., • Results orientation: Must be capable of making commitments, setting priorities, and delivering results in time and on budget in a highly regulated environment., • Situational Adaptability: Sees ahead clearly; can anticipate future concerns., • Develops and maintains effective cross functional relationships and is capable of quickly earning trust and respect., • Must have the ability to travel 10% both domestic and international. Preferred: • Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.), • Demonstrated experience in successfully working with external development partners in delivering complex solutions., • Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments. The Key Working Relationships Internal Partners: • Clinical chemistry and transfusion medicine personnel (current and potential customers), • Development partners The Work Environment The work environment characteristics are representative of an office setting, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Intermittently time is spent in a manufacturing or laboratory environment and include potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Occasional travel, domestically and internationally. Flexible work hours to meet project deadlines Physical Demands No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $125,000 to $135,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-TO1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Strategic Operations Project Manager. The Strategic Operations Project Leader develops strong business proposals and leads complex, crossfunctional projects that improve the efficiency, scalability, and regulatory strength of operations. This role manages strategic initiatives across product changes, process optimization, technology upgrades, and multisite improvements while driving change management and continuous improvement. The ideal candidate excels at influencing without authority, challenging the status quo, and aligning diverse stakeholders across multiple manufacturing sites. This position is in Rochester, NY (Limited Remote) What You'll Do 1. Lead Complex, Cross-Functional Projects * Manage a portfolio of strategic operational improvement projects tied to efficiency, manufacturing scalability, and product lifecycle changes. * Drive crossfunctional planning, execution, risk management, and decision-making across multiple manufacturing locations. * Apply strong project management discipline to keep teams aligned, on track, and accountable. 2. Build Robust Business Justifications & Influence Leadership Decisions * Develop clear, data-driven business cases for proposed projects or changes, including cost-benefit analysis, ROI, risk assessment, resource needs, and strategic alignment. * Translate technical and operational opportunities into compelling narratives that resonate with senior leadership. * Present recommendations, tradeoffs, and decision options to executive stakeholders in a way that enables fast, informed decision-making. * Support annual planning by providing wellstructured rationales for project prioritization and investment needs. 3. Enable Operational Efficiency & Continuous Improvement * Identify, challenge, and streamline inefficient processes across sites and functions. * Apply Lean/CI methodologies to simplify workflows, reduce waste, and improve throughput. * Translate operational problems into structured plans with clear milestones, KPIs, and success criteria. 4. Navigate Regulatory & Quality Requirements * Ensure project execution aligns with medical device regulatory expectations, including design control, change control, validation, and documentation standards. * Partner with Quality and Regulatory teams to ensure compliance without sacrificing execution speed. 5. Drive Organizational Alignment & Change Adoption * Act as a change agent-articulating the "why," aligning stakeholders, and helping teams adopt new processes and ways of working. * Facilitate communication across functions and leadership levels, ensuring transparency and proactive issue escalation. * Influence stakeholders toward datadriven decisions and standardized operational practices. 6. Support Multi-Site Collaboration * Work across several manufacturing facilities to harmonize processes, share best practices, and elevate operational performance. * Build trust and productive working relationships across geographically dispersed teams. Required: * Bachelor's degree in engineering, science, operations, or related field. * 7+ years of project/program leadership experience in regulated industries. * Experience leading complex cross-functional initiatives. * Strong knowledge of design/change control and regulated operations. * Strong change management and influencing skills. * Experience applying Lean/CI methodologies. Preferred: * Advanced degree (MBA, MS, etc.). * PMP or Lean/Six Sigma certification. * Multi-site manufacturing experience. Internal: Operations, Manufacturing, Quality, Regulatory, R&D, Supply Chain, Site Leadership External: Key Suppliers, Equipment/Technology partners The work environment characteristics are representative of a typical office environment with some time in a manufacturing/production floor, lab, or warehouse. Travel up to 10%. Up to 75% of the time you will be standing, walking or sitting Other physical demands include bending, crawling, stooping, vision, grasping, climbing or balancing, kneeling, crouching, talking or hearing, tasting or smelling. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $117,000 to $153,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Software Engineer - Linux C++ to join our R&D Instrument Platforms organization and provide technical leadership in developing features and applications within our portfolio of products. This role focuses on Linux-based device software, real-time control, inter-process communication, and deterministic scheduling implemented in modern C++ (C++20/23) with memory-safe practices. This is an opportunity to shape core architecture and influence the development of safety-critical systems. Responsibilities span the full lifecycle, including requirements, design, implementation, and testing. This position is onsite in Rochester, NY. Note: This position is not currently eligible for visa sponsorship. The Responsibilities • Design and implement modular middleware components for Linux-based device software systems using modern C++ (C++20/23)., • Act as Software SME in design discussions with Product Managers and Systems Engineers to define requirements., • Define system architecture and development processes to ensure long-term maintainability and traceability within a regulated quality management system., • Conduct feasibility analysis and develop proof-of-concepts for middleware solutions., • Contribute to system-wide synchronization, logging, and monitoring infrastructure for observability., • Enforce memory-safe design practices throughout requirement gathering, architecture definition, unit testing, and code reviews., • Develop integration test frameworks for multi-process Linux service environments, • Perform other work-related duties as assigned. The Individual Required: • Minimum of 5 years required with bachelor's or 3 years with master's degree, preferably leading in a medical device environment or equivalent combination of education and experience., • Proficiency in Modern C++ (C++11 minimum, C++20 or newer preferred) with a strong understanding of memory management thread-safety, this is not a web or front-end development position., • Familiarity with Agile development practices and toolchains, including Git, CI/CD integration, and issue tracking platforms such as Jira, GitHub, or Azure DevOps., • Experience developing and testing software for resource-constrained environments, including real-time applications and/or robotic systems., • Strong analytical and debugging skills with a systematic approach to solving complex technical issues., • Experience with automated testing frameworks such as GTest, PyTest, or similar, including test mocking, emulation, and simulation tools for Linux-based device software systems., • Ability to travel 5% or less, domestically. Preferred: • Embedded systems development, including Linux or RTOS., • Design and integration of modular, maintainable software interfaces using Interface Definition Languages (IDLs), versioned APIs (e.g., REST), event-driven or pub/sub architectures, and schema validation (e.g., JSON Schema, XSD) to support cross-language and backend-to-UI interoperability., • Experience or working knowledge of the Rust programming language., • Familiarity with scripting languages such as Python and Bash for automation and tooling., • Proficiency in modern cross-platform software design using contemporary build systems (e.g., CMake, etc.)., • Designing testable architectures and developing deterministic test cases using automated testing frameworks, including mocking, emulation, and simulation tools for Linux-based device software systems. The Key Working Relationships Internal Partners: • Software development partners and suppliers. The Work Environment This role is based at our beautiful waterfront campus with walking trail, fitness center, and full-service onsite cafeteria in the Rochester, NY region. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. Up to 60% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines Physical Demands Must be able to work at desk, standing or sitting for extended periods of time. Other physical demands include bending, kneeling, talking, hearing, and vision. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $100,000 to $120,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-TO1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. * Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. * Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. * Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. * Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. * Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. * Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. * Perform other work-related duties as assigned. Required: * Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. * 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. * Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. * Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. * Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. * Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. * Bias toward action, with a track record of driving execution aligned to organizational strategy. * Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. * Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. * Willingness and ability to travel approximately 10-15%. Preferred: * Advanced degree (MS, PhD, or PharmD) strongly preferred. * Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. * Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. * Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Senior Project Manager is a mid-level individual contributor responsible for managing defined projects and supporting broader programs within the medical diagnostics portfolio. This role ensures effective planning, coordination, and execution of project activities across functional teams. The Senior Project Manager plays a key role in driving project success through collaboration, problem-solving, and process discipline. The Responsibilities * Leads the execution of assigned projects within larger programs, ensuring delivery on time, within scope, and within budget. * Collaborates with teams across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to align project activities and helps resolve issues. * Develops and maintains detailed project plans, timelines, and resource forecasts. Tracks progress and adjusts plans as needed. * Identifies project risks and issues early while working with stakeholders to develop mitigation and resolution strategies. * Maintain accurate project documentation and provide regular status updates to program leadership and stakeholders * Ensures all program activities comply with relevant regulatory standards (e.g., FDA, ISO, etc.). Maintains accurate documentation and audit readiness. * Translates business strategy into actionable program plans. Develops roadmaps, defines milestones, and manages interdependence across functions including R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance, and Marketing. * Serves as the primary liaison between senior leadership and program teams. Facilitates communication, manages expectations, and ensures transparency across all levels of the organization. * Identifies potential risks and implements mitigation strategies. Leads change management efforts to ensure successful adoption of program outcomes. * Provides regular updates to senior leadership, including dashboards, KPIs, and executive summaries. * Champions best practices in program management. Drives process improvements and contributes to the evolution of the business portfolio. * Performs other work-related duties as assigned. The Individual Required: * Bachelor's degree in engineering, Life Sciences, Business, or related field. * PMP certification required or equivalent demonstrated capability. * 7+ years of experience in program/project management, preferably in medical devices, diagnostics, biotech, or healthcare technology. * Proficiency in project management tools (e.g., MS Project, Smartsheet). * Proven track record of leading complex programs with cross-functional teams in a regulated environment (e.g., FDA, ISO, etc.). * Strong business acumen, highly analytical, and strategic thinking. * Exceptional communication (verbal & written), negotiation, and influencing skills. * Ability to summarize complex project and technical subject matter into concise oral and written communications to Executive Management. * Knowledge of timeline and budget management, manufacturing design transfer, Risk Management & Design Control. * General knowledge of R&D, Regulatory, Clinical Affairs, Quality and Operations activities as they relate to the development of a medical device or product. * Demonstrates the ability to lead the program team from inception to product launch using corporate design control processes and procedures. Is able to tailor the design control processes & procedures to fit the specific project needs and circumstances. * Ability to work cohesively with multi-disciplinary scientific working groups. * Must be able to lead, manage, and communicate action items and results from and in meetings in a logical fashion. * Excellent prioritization, organization, and the ability to multitask. * Develop project execution strategy with the ability to independently manage ambiguity. * Experience in QSR (Quality System Regulations) and ISO medical device standards as well as a working knowledge of current FDA, IVDD, and other regulations. * Works independently with minimal guidance; influences across functions and levels. * Leads initiatives with significant business impact. * Solves complex problems requiring innovative thinking and cross-functional collaboration. * Travel: Must be willing to travel up to 10% domestic and international. * This position is not currently eligible for visa sponsorship. Internal Customers: * Finance on budgeting and resource planning. * Clinical Affairs for project deliverables. * Quality Assurance for project activities, design transfer and risk management. * Senior Management on project reporting and planning. * Interacts with Marketing on project deliverables. * Regulatory and Clinical Affairs on project deliverables and planning. * Operations and R&D External Customers: * Third-party vendors and suppliers * Project-specific development partners The work environment is a combination of laboratory, manufacturing, office, & remote home office. No strenuous physical activity, though occasional light lifting of files and related materials is required. 60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. The salary range for this position is $120,000 to $160,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___ #LI-AC1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Instrument Program Manager, Medical Device. The Senior Program Manager is responsible for managing complex programs and projects that span multiple functions within the medical diagnostics portfolio. This role drives execution ensures alignment with business priorities and delivers high-impact results in a regulated environment. The Senior Program Manager leads cross-functional teams through influence and subject matter expertise. This position will be located in Rochester, NY onsite. The Responsibilities • Leads the planning, execution, and delivery of medium to large-scale, complex programs, ensuring scope, schedule, and budget adherence., • Coordinates efforts across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to ensure program success., • Develops detailed project plans, timelines, and resource allocations., • Monitors progress and proactively address issues and risks., • Facilitates regular communication with internal stakeholders, providing updates, resolving conflicts, and ensuring alignment., • Ensures all program activities comply with relevant regulatory standards (e.g., FDA, ISO, etc.). Maintains accurate documentation and audit readiness., • Translates business strategy into actionable program plans., • Develops roadmaps, defines milestones, and manages interdependence across functions including R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance, and Marketing., • Serves as the primary liaison between executive leadership and program teams. Facilitates communication, manages expectations, and ensures transparency across all levels of the organization., • Identifies potential risks and implements mitigation strategies. Leads change management efforts to ensure successful adoption of program outcomes., • Establishes program governance structures. Provides regular updates to senior leadership, including dashboards, KPIs, and executive summaries., • Champions best practices in program management. Drives process improvements and contributes to the evolution of the business portfolio., • Perform other work-related duties as assigned. The Individual Required: • This position is not currently eligible for visa sponsorship., • PMP, PgMP or similar certification required., • 10+ years of experience in program/project management, preferably in medical devices, diagnostics, biotech, or healthcare technology., • Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira)., • Proven track record of leading extraordinarily complex programs with cross-functional teams in a regulated environment (e.g., FDA, ISO, etc.)., • Strong business acumen, highly analytical, and strategic thinking., • Exceptional communication (verbal & written), negotiation, and influencing skills., • Ability to summarize complex project and technical subject matter into concise oral and written communications to Executive, • Management and C-Suite Leadership., • Knowledge of timeline and budget management, manufacturing design transfer, Risk Management & Design Control., • General knowledge of R&D, Regulatory, Clinical Affairs, Quality and, • Operations activities as they relate to the development of a medical device or product., • Demonstrates the ability to lead the program team from inception to product launch using corporate design control processes and procedures. Is able to tailor the design control processes & procedures to fit the specific project needs and circumstances., • Ability to work cohesively with multi-disciplinary scientific working groups., • Must be able to lead, manage, and communicate action items and results from and in meetings in a logical fashion., • Excellent prioritization, organization, and the ability to multitask., • Develop project execution strategy with the ability to independently manage ambiguity., • Experience in QSR (Quality System Regulations) and ISO medical device standards as well as a working knowledge of current FDA, IVDD, and other regulations., • Recognized as a subject matter expert coupled with broad and deep knowledge of program management practices., • Works independently with minimal guidance; influences across functions and levels., • Leads initiatives with significant business impact., • Solves complex problems requiring innovative thinking and cross-functional collaboration. The Key Working Relationships Internal Partners: • Finance on budgeting and resource planning., • Clinical Affairs for project deliverables., • Quality Assurance for project activities, design transfer and risk management., • Senior Management on project reporting and planning., • Interacts with Marketing on project deliverables., • Regulatory and Clinical Affairs on project deliverables and planning., • Third-party vendors and suppliers, • Project-specific development partners The Work Environment The work environment is a combination of laboratory, manufacturing, office, and remote home office. 60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel. Physical Demands No strenuous physical activity, though occasional light lifting of files and related materials is required. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $150,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___.

Job DescriptionDescription: Fisher Associates, P.E., L.S., L.A., D.P.C. has created an internship program to engage college students that are ready to get their foot in the door and gain hands on experience! By using the skills and knowledge gained from academic study and combining with an internship, the student's transition from student to professional is enhanced. Students must be organized, self-motivated, and dependable. We have multiple sectors/service lines in which an internship can be completed as selected by the student. Under direct supervision, the student will perform routine tasks and work on a wide variety of projects gaining a well-rounded learning experience. Who: Students currently enrolled in a Civil Engineering degree program (or related field) What: Obtain hands-on professional work experience with our Transportation, Land Development or Energy groups in various tasks related to design, analysis, and implementation of projects. Where: At any of our office locations! When: Fisher Associates accepts internship applications year-round. Internship timeline is dependent on manager needs and student schedule. The primary function of this role is responsible for, but not limited to, the following: • Exhibit behaviors that align with the Fisher Values: Aspire to Excellence, Teamwork and Respect, Owning our Results and Empowered Employees., • Establish and maintain strong client relationships adhering to the Fisher Clientship philosophy., • Perform engineering analysis and design., • Prepare cohesive and organized engineering calculations., • Assist technical staff with day-to-day design tasks for several types of projects., • Conduct basic engineering functions including design calculations and cost estimating under supervision., • Collaborate as a member of the team to realize project deliverables and deadlines., • Prepare construction specifications under direct supervision., • Assist senior engineers or designers with organizing/preparing reports, studies, or bid packages., • Participate in site visits and field inspections to gather data and assess project conditions, as needed. Fisher Associates, P.E., L.S., L.A., D.P.C. is a consulting engineering and professional services firm serving the Transportation, Land Development and Energy market sectors. Our comprehensive services include landscape architecture, planning, engineering, environmental, survey, GIS and construction representation. Fisher Associates, P.E., L.S., L.A., D.P.C. is headquartered in Rochester NY, with eight offices throughout NY, PA and TX. The culture at Fisher is friendly, respectful, and a true team environment. We own our responsibilities and results, continuously seeking to improve and empower our employees. Requirements: Education & Experience • Currently pursuing a bachelor’s degree in Civil Engineering, Civil Engineering Technology or related field., • Strong academic performance in relevant coursework., • Aspire to excellence, consistently seek to improve, and demonstrate high quality work at all levels., • Team player: collaborate effectively at all levels; treat coworkers, clients and vendors with respect in all interactions; seek to listen effectively, understand others, and build trust., • Own and accept responsibility for results., • Honest, transparent, and trustworthy., • Proactive, self-motivated, and eager to learn., • Strong critical thinking and problem-solving skills., • Ability to consistently demonstrate sound judgement., • Excellent and professional communication skills both written and verbal., • Excellent organizational, project management and time management skills., • Ability to work in a fast-paced environment and manage multiple tasks simultaneously., • Strong attention to detail., • Exhibit flexibility with assignments, workflow, or project changes., • Listen and respond to feedback in a positive manner. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Prolonged periods sitting at a desk and working on a computer., • Must be able to lift to 15 pounds at a time., • Must be able to travel to various project sites., • Must be able to access and navigate construction sites and job areas., • Ability to transverse uneven grounds. Salary Range: $23/hour Actual compensation may vary based on relevant experience, qualifications/education, and other factors. The salary range is not necessarily reflective of the actual total compensation that may be earned nor promises any specific pay for any specific employee. Salary range excludes monetary value of benefits. Fisher Associates embraces a family-feel culture and welcomes all newcomers with open arms. Fisher Associates does not discriminate in hiring or employment on the basis of age, race, creed, color, national origin (including ancestry), religion, gender or sex, sexual orientation (including transgender status, gender identity or expression), pregnancy (including childbirth, lactation, and related medical conditions), disability, reproductive health decision making (including, but not limited to, the decision to use or access a particular drug, device, or medical service), marital status, partnership status, caregiver status, domestic violence victim status, familial status, military status, unemployment status, genetic information (including genetic characteristics), citizenship or immigration status, or any other protected status under federal, state, or local laws.

Job Description PEKO Precision Products: We Make Products That Matter PEKO is a full-service, debt-free, privately-owned contract manufacturer with over 50 years embedded in the Rochester, NY community. In collaboration with our valued business partners, we deliver new product development (NPI) strategies for product commercialization and provide solutions in the medical, industrial, defense, and renewable energy industries. Enriching life is a crucial component of what we do daily. The Opportunity: Quality Engineer Your Role: Under the direction of the Quality Director, you will assist in elevating and systematizing engineering and manufacturing processes. Daily activities will require you to proactively identify potential issues to mitigate risk, improve product quality, manage industry and regulatory compliance and assist in delivering corporate strategic initiatives. Essential Functions: • Analyzes quality performance data and metrics to identify and drive improvement opportunities. Actively promote and participate in a cross-functional teamwork environment. * Facilitate and promote the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action for customer complaints and internal nonconformances. * Understand and promote overall compliance with AS9100/ISO9001 and 13485 specifications as they relate to product conformance and contractual requirements. * Understanding of inspection methodologies used to determine compliance for machined and assembled products. * Manage, conduct, and support internal and external audits, publishing findings and recommendations. * Lead in the implementation of assurances, process controls, and corrective and preventative actions (CAPA) related systems designed to meet or exceed internal and external requirements. * Drives continuous improvement and prevention of future failures by helping facilitate the implementation of corrective action. * May be accountable for projects/ programs and developing methods and parameters, project methodology, and/ or project proposals. * Demonstrate a productive work ethic and commitment to quality that sets the standard for PEKO Standards. Associate degree in Engineering or equivalent. * 2+ years of quality control experience in a manufacturing environment * 4+ years of experience utilization of Quality Management Systems (QMS) * 4+ years of creating and/or managing Design History Files (DHF) and Device Master Records (DMR). * Knowledge of ISO 13485 and AS9100; ability to establish quality protocols and procedures that align with requirements. Preferred Qualifications: * Bachelor’s degree in engineering or equivalent * Strong communication, negotiation, team moderation skills, and ability to manage time and workload constraints. * Good understanding of QA methodologies, tools, and processes. * Knowledge in the application of quality methods and problem-solving tools (TQM, Six Sigma, 8D, 5-Why, Lean Manufacturing, or other continuous improvement methodologies). Work Authorization: US Persons PEKO Perks: * Competitive Compensation * Tuition Reimbursement (IRS Allowable pre-tax Max) * 401K, Medical, Dental, Vision * Flexible Spending & Health Savings Accounts * Life, Short and Long-Term Disability * Recognition Awards & Discretionary Benefits Our Core Values: * Compassion: We care about our talented and loyal PEKO family. * Safety: We are committed to providing a safe, clean, and positive workplace. * Integrity: We believe in transparency, honesty, and respect for all stakeholders. * Agility: We are dedicated to maintaining an agile and financially prudent organization. * Endurance: We foster the belief that PEKO people are resilient problem-solvers impacting the future. * Get a glimpse of why we are #PEKOProud: #PEKOProud - YouTube Other: * This position may require you to follow other job-related instructions and to perform other job-related duties as requested or assigned, subject to all applicable state and federal laws. Duties, responsibilities, and activities may change at any time with or without notice A reasonable estimate of the compensation range for this position is $60,000 - $89,000 per year. The wage range for this role considers a wide range of factors when making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational requirements.. Powered by JazzHR bprvXbhRjI

Job Description Project Manager – Precast Transportation and Underground Structures Design | Civil Engineering Lead Precast Projects That Move Communities Forward Are you a skilled Civil Engineering Project Manager with experience in precast concrete design for transportation infrastructure and underground structures projects? Fisher Associates is seeking a Project Manager to lead precast projects from concept through completion. In this role, you'll manage client relationships, guide multidisciplinary teams, and ensure the quality and accuracy of precast design deliverables. You'll be part of a collaborative, people-first culture where your leadership drives results and your growth is supported. At Fisher, your voice matters and your work makes an impact. Apply today to lead meaningful projects and bring innovative transportation solutions to life. About Fisher Associates Fisher Associates is a multidisciplinary design services firm headquartered in Rochester, NY, with eight locations nationwide. The firm provides civil/site engineering, transportation engineering, electrical engineering, landscape architecture, architecture, planning, environmental, surveying, GIS, construction inspection, precast engineering and construction engineering services to public and private sector clients across numerous markets. Why You’ll Love Working at Fisher · You are empowered to achieve exceptional results through collaboration and ownership. · Your voice matters in our inclusive and transparent culture, where accessible leadership genuinely welcomes ideas and feedback. · Your growth is our priority. We offer clear career paths, tuition assistance, and ongoing learning opportunities to support your development. · You thrive in a culture that celebrates fun and fosters a relaxed, easy-going atmosphere, so you can bring the best of yourself to work every day. · Your journey is shaped by a culture of mentorship, where experienced colleagues guide your growth and you, in turn, inspire others. · Your success is supported by our flexible work environment empowering you to thrive both professionally and personally. What You’ll Do as a Precast Project Manager · Collaborate with internal teams, clients, subconsultants and agencies to ensure seamless project delivery. · Successfully lead projects from initial setup through planning, safety analysis, and project kick-off. · Manage project budgets, scope, schedule, and staffing to stay on plan. · Oversee project billing, client updates, QA/QC of deliverables, and project closeout. · Lead transportation and underground structures precast design projects, ensuring compliance with industry, regulation, and safety standards. · Support the preparation of project proposals by collaborating with senior staff and technical teams. · Coordinate with design teams to develop detailed plans, specifications, drawings and bid packages. · Perform technical reviews and provide guidance to resolve design challenges. · Manage a project team, fostering a collaborative and productive work environment. · Assign tasks, monitor progress, and provide guidance to ensure project milestones are met. · Mentor and develop team members to enhance their technical and professional skills. What We Offer Your Impact Matters, Your Career Thrives. Work on engaging precast engineering projects and experience first-hand the positive changes you create in your own community. Engage in diverse and challenging project opportunities that will help you grow and advance your career. We offer competitive salaries and benefits, including: • Medical, Dental & Vision Insurance, • 401(k) Plan, • Company-paid Life and Disability Insurance, • Hybrid Work Schedule, • Generous PTO and Paid Holidays, • Strong Work-life Balance, • Shareholders Program · Engage with dynamic groups such as the Community Impact and Fun Committees, Fisher Minds (ERG), and the Employee Advisory Group Salary Range $95,000-$130,000 Actual compensation may vary based on relevant experience, qualifications/education, and other factors. The salary range is not necessarily reflective of the actual total compensation that may be earned nor promises any specific pay for any specific employee. Salary range excludes monetary value of benefits. What You Bring, Your Expertise as a Precast Project Manager · Precast project management experience · Professional Engineering License (PE) preferred or ability to obtain it · Familiarity with ACI 318, ACI 350, ASCE-7, AASHTO and IBC codes • Professional performance standards aligned with Fisher’s Mission, Vision, and Core Values, • Highly adaptable and proactive in meeting deliverables and deadlines., • Dedicated to fostering trusting relationships through collaboration integrity, respect, and active listening, • Curious, improvement-minded, and always seeking better solutions, • Embrace feedback constructively and use it as an opportunity for growth. Equal Employment Opportunity Statement Fisher Associates is committed to fostering a diverse and inclusive workplace where all individuals are respected, valued, and empowered to thrive. We do not discriminate in hiring or employment on the basis of age, race, creed, color, national origin (including ancestry), religion, gender or sex, sexual orientation (including transgender status, gender identity or expression), pregnancy (including childbirth, lactation, and related medical conditions), disability, reproductive health decision making (including, but not limited to, the decision to use or access a particular drug, device, or medical service), marital status, partnership status, caregiver status, domestic violence victim status, familial status, military status, unemployment status, genetic information (including genetic characteristics), citizenship or immigration status, or any other protected status under federal, state, or local law.

Job Description Project Manager – Precast Transportation and Underground Structures Design | Civil Engineering Lead Precast Projects That Move Communities Forward Are you a skilled Civil Engineering Project Manager with experience in precast concrete design for transportation infrastructure and underground structures projects? Fisher Associates is seeking a Project Manager to lead precast projects from concept through completion. In this role, you'll manage client relationships, guide multidisciplinary teams, and ensure the quality and accuracy of precast design deliverables. You'll be part of a collaborative, people-first culture where your leadership drives results and your growth is supported. At Fisher, your voice matters and your work makes an impact. Apply today to lead meaningful projects and bring innovative transportation solutions to life. About Fisher Associates Fisher Associates is a multidisciplinary design services firm headquartered in Rochester, NY, with eight locations nationwide. The firm provides civil/site engineering, transportation engineering, electrical engineering, landscape architecture, architecture, planning, environmental, surveying, GIS, construction inspection, precast engineering and construction engineering services to public and private sector clients across numerous markets. Why You’ll Love Working at Fisher · You are empowered to achieve exceptional results through collaboration and ownership. · Your voice matters in our inclusive and transparent culture, where accessible leadership genuinely welcomes ideas and feedback. · Your growth is our priority. We offer clear career paths, tuition assistance, and ongoing learning opportunities to support your development. · You thrive in a culture that celebrates fun and fosters a relaxed, easy-going atmosphere, so you can bring the best of yourself to work every day. · Your journey is shaped by a culture of mentorship, where experienced colleagues guide your growth and you, in turn, inspire others. · Your success is supported by our flexible work environment empowering you to thrive both professionally and personally. What You’ll Do as a Precast Project Manager · Collaborate with internal teams, clients, subconsultants and agencies to ensure seamless project delivery. · Successfully lead projects from initial setup through planning, safety analysis, and project kick-off. · Manage project budgets, scope, schedule, and staffing to stay on plan. · Oversee project billing, client updates, QA/QC of deliverables, and project closeout. · Lead transportation and underground structures precast design projects, ensuring compliance with industry, regulation, and safety standards. · Support the preparation of project proposals by collaborating with senior staff and technical teams. · Coordinate with design teams to develop detailed plans, specifications, drawings and bid packages. · Perform technical reviews and provide guidance to resolve design challenges. · Manage a project team, fostering a collaborative and productive work environment. · Assign tasks, monitor progress, and provide guidance to ensure project milestones are met. · Mentor and develop team members to enhance their technical and professional skills. What We Offer Your Impact Matters, Your Career Thrives. Work on engaging precast engineering projects and experience first-hand the positive changes you create in your own community. Engage in diverse and challenging project opportunities that will help you grow and advance your career. We offer competitive salaries and benefits, including: • Medical, Dental & Vision Insurance, • 401(k) Plan, • Company-paid Life and Disability Insurance, • Hybrid Work Schedule, • Generous PTO and Paid Holidays, • Strong Work-life Balance, • Shareholders Program · Engage with dynamic groups such as the Community Impact and Fun Committees, Fisher Minds (ERG), and the Employee Advisory Group Salary Range $95,000-$130,000 Actual compensation may vary based on relevant experience, qualifications/education, and other factors. The salary range is not necessarily reflective of the actual total compensation that may be earned nor promises any specific pay for any specific employee. Salary range excludes monetary value of benefits. What You Bring, Your Expertise as a Precast Project Manager · Precast project management experience · Professional Engineering License (PE) preferred or ability to obtain it · Familiarity with ACI 318, ACI 350, ASCE-7, AASHTO and IBC codes • Professional performance standards aligned with Fisher’s Mission, Vision, and Core Values, • Highly adaptable and proactive in meeting deliverables and deadlines., • Dedicated to fostering trusting relationships through collaboration integrity, respect, and active listening, • Curious, improvement-minded, and always seeking better solutions, • Embrace feedback constructively and use it as an opportunity for growth. Equal Employment Opportunity Statement Fisher Associates is committed to fostering a diverse and inclusive workplace where all individuals are respected, valued, and empowered to thrive. We do not discriminate in hiring or employment on the basis of age, race, creed, color, national origin (including ancestry), religion, gender or sex, sexual orientation (including transgender status, gender identity or expression), pregnancy (including childbirth, lactation, and related medical conditions), disability, reproductive health decision making (including, but not limited to, the decision to use or access a particular drug, device, or medical service), marital status, partnership status, caregiver status, domestic violence victim status, familial status, military status, unemployment status, genetic information (including genetic characteristics), citizenship or immigration status, or any other protected status under federal, state, or local law.

Job DescriptionDescription: Join Fisher Associates as a Transportation Construction Inspector in Rochester, NY! Work on meaningful NYSDOT and municipal projects with a collaborative, growth-focused team! Fisher Associates is hiring Transportation Construction Inspectors for exciting work on NYSDOT and municipal highway and bridge projects in the greater Rochester, NY area. This is your opportunity to work on meaningful local infrastructure projects while advancing your career with a collaborative and respected consulting engineering firm. Apply today to shape your community with us! For more information, contract Danny at: or call (412) 576-6534. About Fisher Associates: At Fisher Associates, our people are the heart of everything we do. As a multidisciplinary design services firm with eight locations nationwide, we empower our team members to drive meaningful change through their work. Our services span civil/site engineering, transportation engineering, electrical engineering, landscape architecture, architecture, planning, environmental services, surveying, GIS, construction inspection, precast, and construction engineering, each offering opportunities to shape communities and improve lives. When you join Fisher, you’re not just building a career, you’re helping build a better world. Why You’ll Love Working at Fisher • You are empowered to achieve exceptional results through collaboration and ownership., • Your voice matters in our inclusive and transparent culture, where accessible leadership genuinely welcomes ideas and feedback., • Your growth and success is our priority. We offer clear career paths, tuition assistance, and ongoing training opportunities to support your career development., • You thrive in a culture that celebrates fun and fosters a relaxed, easy-going atmosphere, so you can bring the best of yourself to work every day., • Conduct regular on-site inspections to verify that construction activities align with approved plans, specifications, and applicable codes., • Ensure that construction projects comply with local, state, and federal codes and regulations., • Maintain detailed records of inspections, including photographs, notes, and reports., • Prepare inspection reports outlining findings, discrepancies, and corrective actions required., • Communicate with contractors, project managers, and engineers to discuss inspection results and address any issues., • Provide guidance on corrective measures to bring non-compliant elements up to standard., • Monitor the quality of construction materials and workmanship to ensure they meet specified standards., • Identify and report any deviations from approved plans and specifications., • Evaluate construction sites for adherence to safety protocols and regulations., • Report and address any safety hazards or violations promptly., • Collaborate with project managers, architects, and engineers to resolve issues and ensure construction projects progress smoothly. Your Impact Matters, Your Career Thrives. Work on engaging projects and experience first-hand the positive changes you create in your own community. Engage in diverse and challenging project opportunities that will help you grow and advance your career. We offer competitive salaries and benefits, including: • Medical, Dental and Vision insurance, • 401k retirement plan, • Company-paid life and disability insurance, • Generous PTO, • Comprehensive benefit options to support your well-being, financial security, and peace of mind., • Annual gear allowance for work boots or other gear, • Monthly cell phone reimbursement, • Annual wellness reimbursement for things that keep you well including gym memberships, home security systems, and more!, • NICET certification or equivalent experience required, • Proven field inspection on transportation projects, • Knowledge of NYSDOT specifications, construction standards, and QA/QC principles, • Ability to manage project priorities effectively, • Professional performance standards aligned with Fisher’s Mission, Vision, and Core Values., • Demonstrated high-quality work and ability to problem solve applying critical thinking, and sound judgment to challenges., • Driven to take ownership of your projects, prioritize your tasks effectively, and thrive in a dynamic, fast-paced environment that fosters personal and professional growth., • Highly adaptable and proactive in meeting deliverables and deadlines, • Dedicated to fostering trust and collaboration through integrity, respect, and active listening in client and team relationships., • Have a sense of curiosity, always looking for a better way, and a continuous improvement mindset. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Travel to assigned project site required, • Must be able to lift up to 30 pounds at a time., • Must be able to access and navigate construction site, • Ability to traverse uneven grounds. #LI-DNP

Job DescriptionDescription: Are you a skilled surveyor with a passion for precision and a knack for problem-solving? Fisher Associates is seeking a dynamic Project Surveyor to join our team! In this role, you’ll be at the heart of our projects, ensuring that our land surveying services are not only accurate but also aligned with our high standards. You’ll play a vital role in bridging the gap between different disciplines within our project teams, ensuring that every project runs smoothly from start to finish. If you’re ready to make a big impact on exciting and diverse projects, we want to hear from you! Who We Are: Fisher Associates, P.E., L.S., L.A., D.P.C. is a consulting engineering and professional services firm serving the Transportation, Land Development and Energy market sectors. Our comprehensive services include landscape architecture, planning, engineering, environmental, survey, GIS and construction representation. We are headquartered in Rochester NY, with eight offices throughout NY, PA and TX. Why a Career with Fisher Associates? • Be Heard, Be Valued: Our leadership team is accessible and welcomes your feedback and ideas., • There is No “I” in Team: Every team member matters and contributes to our success by owning their role on the team. Contribute your creative ideas and expertise to our exceptional groups., • Transparency Matters: We keep you informed with frequent communications and quarterly financial reviews., • Long-Term Client Relationships: Our goal is to build long-lasting client relationships while delivering high-quality solutions., • Community Service: We are passionate about giving back and creating a legacy of service that improves equity, access, dignity and joy for members of our diverse communities., • Work on Local Projects: Experience the positive change you create in our own community., • Diverse Project Opportunities: The diverse comprehensive services we offer translate into challenging and engaging learning & growth opportunities., • Growth is Your Journey: Advance your career with clearly defined career paths, tuition assistance and ongoing training to support your professional goals. Actual compensation may vary based on relevant experience, qualifications/education, and other factors. The salary range is not necessarily reflective of the actual total compensation that may be earned nor promises any specific pay for any specific employee. Salary range excludes monetary value of benefits. The primary function of this role is responsible for, but not limited to, the following: • Supervises survey technicians, field crews, and CADD technicians on the project team., • Performs routine and complex survey calculations and control adjustments., • Performs, assigns, or assists with records research., • Performs, assigns, or assists with CADD drafting assignments., • Analyzes boundary evidence and parcel/ROW records to determine property boundaries and Rights of Way., • Determines and documents property boundaries, easements, and land ownership details to ensure compliance with legal regulations., • Creates detailed topographic maps and surveys to provide essential data for project planning and design., • Maintains positive client relationships, understanding project requirements, and facilitating all deliverables to ensure an outstanding customer experience using Clientship Philosophy., • Provides QA/QC on survey work completed for all sectors., • Associate or Bachelor's degree in surveying, geomatics, civil engineering, or a related field., • Experience in surveying software and equipment, including AutoCAD, GPS, total stations, and data collectors., • Previous experience in land surveying, • Must be knowledgeable in all aspects of Land Surveying, including boundary determinations, control adjustments, topographic surveying/mapping, NYSDOT Standards and Procedures, and ALTA requirements., • Proficiency in AutoCAD Civil 3D and MicroStation preferred., • Exhibit behaviors that align with the Fisher Values: Aspire to Excellence, Teamwork and Respect, Owning our Results and Empowered Employees., • Aspire to excellence, consistently seek to improve, and demonstrate high-quality work at all levels., • Team player: collaborate effectively at all levels; treat coworkers, clients, and vendors with respect in all interactions; seek to listen effectively, understand others, and build trust., • Own and accept responsibility for results., • Honest, transparent, and trustworthy. Ability to identify and handle priority and/or sensitive issues with discretion and a commitment to confidentiality., • Proactive, results-oriented, self-motivated, and eager to learn., • Strong critical thinking and problem-solving skills., • Ability to consistently demonstrate sound judgement., • Excellent organizational, project management and time management skills, • Ability to work in a fast-paced environment and manage multiple tasks simultaneously., • Strong attention to detail., • Exhibit flexibility with assignments, workflow, or project changes., • Listen and respond to feedback in a positive manner. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Ability to stand and walk for long periods of time and distance., • Prolonged periods sitting at a desk and working on a computer., • Must be able to lift up to 50 pounds at a time., • Traveling on an occasional basis to project sites located throughout New York, • Must be able to access and navigate construction sites and job areas, • Ability to transverse uneven grounds Fisher Associates does not discriminate in hiring or employment on the basis of age, race, creed, color, national origin (including ancestry), religion, gender or sex, sexual orientation (including transgender status, gender identity or expression), pregnancy (including childbirth, lactation, and related medical conditions), disability, reproductive health decision making (including, but not limited to, the decision to use or access a particular drug, device, or medical service), marital status, partnership status, caregiver status, domestic violence victim status, familial status, military status, unemployment status, genetic information (including genetic characteristics), citizenship or immigration status, or any other protected status under federal, state, or local laws.

Job Description Overview We are partnering with a growth-stage medical device manufacturer to recruit a Regulatory Affairs Specialist to join their team in New York State. Our client designs and manufactures regulated medical devices distributed through clinical and hospital channels and has an established, active installed base. As the business scales, they are expanding their Regulatory & Quality operations to support increasing change activity, audit readiness, and global compliance needs. This is a hands-on, high-ownership individual contributor role with visible impact across the regulatory and quality spectrum. The right person will be execution-driven, comfortable in a lean cross-functional environment, and motivated by accountability and broad scope. Key Responsibilities Quality Management System (QMS) • Track and drive CAPAs, nonconformances, and corrective actions through to closure, • Maintain and support an ISO 13485-aligned QMS, including document and record control, • Support training record upkeep and assist with onboarding new employees, • Assist with external audit preparation, participation, and follow-up activities, • Support the internal audit program, including planning and execution, • Support UDI/GUDID maintenance and labeling review workflows, • Contribute to change control and supplier quality documentation workflows, • Support supplier and contract manufacturer quality documentation activities, • Assist with monitoring evolving compliance requirements and integrating updates into internal processes, • Support risk management files, DHF updates, and design change documentation, • Serve as a dependable execution partner across product, supplier, and change control activities, • Work alongside Engineering, Operations, and Regulatory leadership in weekly and ad hoc team meetings, • Experience with eQMS and/or document control systems, • Bachelor’s degree in a relevant technical, engineering, or life sciences discipline (or equivalent demonstrated experience in medical device regulatory/quality), • 3–7 years of hands-on experience in medical device quality or regulatory affairs in an ISO/FDA-regulated environment, • Practical working knowledge of ISO 13485 QMS processes, including document control, CAPA, nonconformance management, and change control, • Direct exposure to global audit programs (e.g., MDSAP—supporting, preparing for, and/or participating), • Proven ability to produce and maintain detailed, audit-ready documentation, • Ownership-oriented working style with the ability to manage tasks independently through completion, • Comfortable escalating compliance concerns and communicating effectively in a cross-functional, lean environment, • U.S. work authorization required; standard pre-employment background screening appliesPreferred Qualifications, • Familiarity with applicable quality system regulations (e.g., FDA QSR / 21 CFR Part 820) requirements, • RAC, ASQ (CQA or CQE), or ISO 13485 internal/lead auditor certification, • ISO 14971 risk management experience or certification, • Experience in a regulated medical device environment, • Background in a small-to-mid-sized, privately held, or growth-stage company where roles are broad and cross-functional, • Experience with regulated health technology hardware/software (e.g., connected devices, diagnostics, monitoring, or adjacent platforms) Benefits Salary: $75,000 – $95,000 base salary, commensurate with experience. Benefits: Comprehensive benefits package including medical, dental, vision, retirement plan, and paid time off. Equal Employment Opportunity and Non-Discrimination Policy Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status. Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected. Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations. Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location. Compliance with Laws: Both Keller Executive Search and our clients comply with federal, state, and local laws governing nondiscrimination in employment. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Workplace Harassment: Both Keller Executive Search and our clients expressly prohibit any form of workplace harassment based on race, skin color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. E-Verify Participation: Keller Executive Search and/or our clients may participate in E-Verify. Information about E-Verify participation will be provided during the application process where applicable. Use of Artificial Intelligence in Recruitment: Keller Executive Search and our clients may use artificial intelligence (AI) tools to assist in the recruitment and candidate evaluation process. These tools are used exclusively to support human decision-making by helping to review and assess candidate qualifications and materials. AI is never used to automatically reject, disqualify, or make final hiring decisions about candidates. All AI-assisted evaluations are reviewed by experienced recruitment professionals, and all hiring decisions are made by qualified human recruiters. Our use of AI is designed to enhance fairness, consistency, and efficiency while maintaining our commitment to equal employment opportunity and non-discrimination principles. Privacy and Pay Equity: California Residents: For more information about the categories of personal information we collect for recruiting and employment purposes, please review our Privacy Policy at . Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available. Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws. State-Specific Information: Rhode Island: We do not request or require salary history from applicants. Connecticut: We provide wage range information upon request or before discussing compensation. New Jersey: We do not inquire about salary history unless voluntarily disclosed. Veteran Status: Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process. Genetic Information: In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law. Local Laws: Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate. Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.

Job Title: Salesforce Project Manager.Location: NY/NJ (Hybrid – 3 days/week).Seeking a Senior Project Manager to lead Salesforce B2B delivery projects, managing end-to-end execution, stakeholders, and cross-functional teams.Manage multiple Salesforce projects (scope, timeline, budget).Drive projec

Design and analysis of circuits and components utilizing ADS, Matlab and various design and simulation tools. Working with design engineering and manufacturing teams to introduce new designs into manufacturing. Mitigating component shortages through qualifying alternatives or redesigning circuits an

Design mechanical components and systems using SolidWorks and GD&T principles. Strong mechanical design skills and proficiency in SolidWorks.

Duration: 12 Months Contract (with possible extension) Job Description: Senior project manager to support various projects for client Advanced Optics (AO) division.Responsible for leading technical teams and working with internal and/or external customers to define and execute programs and meet cust

Support risk analysis activities, including design and process FMEA. Use of statistical software and techniques for analysis of data, including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE).

The Engineering Project Manager oversees the planning, coordination, and execution of engineering projects from concept through completion.This role ensures that projects are delivered on time, within scope, and within budget while maintaining compliance with quality, safety, and performance standar

Design and analysis of circuits and components utilizing ADS, Matlab and various design and simulation tools. Working with design engineering and manufacturing teams to introduce new designs into manufacturing. Ability to design and conduct engineering experiments and act upon test results.

Provides construction management, architectural design, and code compliance support in the Facilities Management group. Responsibilities cover all phases of project management including evaluation of requirements, estimating, scheduling, budget management, design oversight, construction management,

JK Executive Strategies is proud to partner with a General Contractor in search of a Project Manager to join its team!.Our client is seeking an experienced Project Manager to lead commercial construction projects from preconstruction through closeout.This role is ideal for a hands-on professional wh

A comprehensive benefit package including medical insurance with employer contribution towards premium, medical opt out credit, employer paid life and long-term disability insurance!.

Design and analysis of circuits and components utilizing ADS, Matlab and various design and simulation tools. Working with design engineering and manufacturing teams to introduce new designs into manufacturing. Job Title: Senior Specialist, Electrical Engineer (RF Design).

At Fisher Associates, we are a multidisciplinary design services firm with nine locations nationwide. Lead design strategy and collaborate with teams, clients, partners, and stakeholders to align with client goals and ensure seamless project delivery. Familiarity with PennDOT design standards prefer

Demonstrated ability to produce Hardware Design Specifications and other relevant design documentation. Perform sustaining engineer activities for legacy products by mitigating component shortages through qualifying alternatives or redesigning circuits and sub-assemblies to address obsolescence. The

Leads or coordinates cross-functional project/program teams from design to delivery of fully-developed products that are ready for customer use. Investigates facts and develops solutions to problems during the design and planning phases. Leads or coordinates cross-functional project/program teams fr

PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and family sick leave, and more. As PwC is an equal opportunity employer, all qualified applicants will receive consideration for employment at PwC without regard to race; color; religion;

At Fisher Associates, we are a multidisciplinary design services firm with nine locations nationwide. Lead design strategy and collaborate with teams, clients, partners, and stakeholders to align with client goals and ensure seamless project delivery. Familiarity with PennDOT design standards prefer

Types of projects include, but are not limited to, main and service replacements, system improvements, pressure upgrades, new business main extensions, highway improvements, regulator station and facility design, critical crossing and horizontal directional drilling design, odorization and pipe cond