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Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Department: Quality Location: PTI Tech, Clifton NJ Reports To: Director of Quality Mission To uphold and advance the highest standards of quality across all stages of manufacturing—ensuring compliance with AS9100 and customer-specific requirements through robust documentation, risk management, and process validation. This role exists to proactively prevent quality issues, support internal and customer-facing investigations, and strengthen PTI’s reputation as a trusted partner for mission-critical components. Competencies – What This Person Must Be Standards-Driven: Understands and applies AS9100, ISO 9001, MIL-STD-1916 and customer-specific standards; ensures audits, validations, and ongoing operations meet all requirements. Root Cause Problem Solver: Leads investigations using 8D, 5 Whys, and Ishikawa methods to ensure sustainable corrective actions. Process Control Advocate: Uses SPC, PFMEA, control plans, and capability studies to ensure consistent, capable production. Metrics-Driven: Uses data analysis to monitor trends, reduce scrap, and eliminate recurrence of quality issues. Customer-Focused: Communicates clearly with aerospace, defense, and other high-stakes clients; drives issues to closure and delivers timely updates. Cross-Functional Collaborator: Partners with Engineering, Manufacturing, and Production teams to align on requirements, validate processes, and resolve issues quickly. Detail-Oriented: Manages documentation and compliance requirements with accuracy including FAIRs, PPAPs, CAPA records, SOPs, and quality alerts with full traceability. Self-Directed and Proactive: Takes initiative to identify and resolve quality risks without being prompted and with minimal supervision; follows through on actions with rigor and accountability. Key Responsibilities • Drive quality improvements through Gage R&R studies, Statistical Process Control (SPC), Six Sigma, and Lean Manufacturing tools., • Lead investigations into internal and external quality issues; document findings and ensure timely resolution., • Perform root cause analysis using structured problem-solving methods (8D, 5 Whys) and verify the effectiveness of corrective and preventive actions (CAPA)., • Coordinate timely responses to Supplier Corrective Action Requests (SCAR), Non-Conformance Reports (NCR), customer complaints, and quality-related queries., • Prepare and maintain First Article Inspection Reports (AS9102), Production Part Approval Process (PPAP-AS9145) documentation, and validation (IQ/OQ/PQ)., • Lead risk assessments (PFMEA) and develop control plans to mitigate quality risks., • Track and analyze defects and scrap data to identify trends and prioritize corrective actions., • Collaborate with manufacturing and engineering to improve processes and define inspection criteria., • Own inspection processes, including CMM (Zeiss – Calypso), OGP, and Keyence programming, as well as inspection fixture design (SolidWorks preferred)., • Oversee QC personnel training in partnership with manufacturing engineering to establish visual standards and develop work instructions., • Maintain SOPs, work instructions, inspection procedures, and training logs in compliance with AS9100., • ≥ 98% Quality Shipments, • ≥ 90% Gage R&R Pass Rate, • ≥ 1.33 Cpk for Stable Processes, • ≤ 3% Internal Scrap Rate on assigned processes, • ≥ 95% CAPA Effectiveness, • ≥ 95% On-Time Submission of FAIRs, PPAPs, SCAR’s, and CAPA’s, • Bachelor’s degree in Mechanical, Manufacturing, or a related Engineering field, • 3–5+ years of quality engineering experience in injection molding or precision manufacturing, • Working knowledge of AS9100, ISO 9001, and MIL-STD-1916, • Experience with FAIR, PPAP, SPC, PFMEA, control plans, and CAD (SolidWorks preferred), • Proficiency in statistical tools (Minitab, JMP, Excel) and QMS/ERP systems, • ASQ Certified Quality Engineer (CQE) or Six Sigma certification, • Experience in the defense, aerospace, or medical device industries, • Hands-on inspection experience, including CMM, optical, or non-contact methods, • Ability to stand and walk on the production floor for extended periods, • Capable of lifting up to 40 lbs and accessing production and inspection equipment, • Manual dexterity for handling tools, parts, and inspection equipment, • Visual acuity sufficient to read prints, inspect parts, and identify quality defects, • Manufacturing facility with exposure to injection molding machines, CNC equipment, and secondary operations, • Requires use of PPE, including safety glasses, gloves, and hearing protection, • Frequent collaboration with production, maintenance, and engineering teams on the floorCompany DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job DescriptionAbout Voyant: Voyant Photonics, based in the heart of New York City, is transforming machine perception with a new class of LiDAR devices that are compact enough to fit in the palm of your hand and powerful enough to measure range, velocity, and reflectivity with unparalleled accuracy. By leveraging cutting-edge silicon photonic chips smaller than your fingertip, we deliver sensors that are not only revolutionary in performance but also affordable enough to integrate into any system. Our technology disrupts the status quo of bulky, expensive, and power-hungry LiDAR systems, making high-precision sensing accessible for widespread adoption in robotics, autonomous vehicles, drones, industrial automation, and beyond. With Voyant, the next generation of machines can see, understand, and navigate the world like never before. Discover how we’re redefining what’s possible by making real products out of cutting-edge research in silicon photonics. Position Overview: We are seeking a highly motivated and self-driven Photonics Test Engineer to take ownership of test development and operations for our cutting-edge silicon photonics FMCW LiDAR technology. This is a hands-on role where you will develop and execute advanced test methodologies, ensure rigorous validation of our photonics devices, and work closely with a multidisciplinary engineering team. You will set a high standard for test execution, troubleshooting, and process improvements, leading by example through direct contributions and technical expertise. Key Responsibilities: * Develop and execute design verification tests, analyze results, and provide feedback to improve device performance. * Define and implement both die-level and wafer-level test solutions in collaboration with design, product, and packaging teams. * Develop production test solutions for silicon photonics components to ensure manufacturability and scalability. * Optimize and standardize test and analysis methodologies to improve repeatability and accuracy. * Bring up, manage, and operate automated wafer-level test (WLT) probers for silicon photonics devices. * Perform routine setup calibrations and ensure quality control in test processes. * Identify and mitigate test challenges, ensuring the execution of large-scale technical projects in a timely and efficient manner. Qualifications: * Education: Bachelor's, Master’s, or PhD in Electrical Engineering, Photonics, Optics, Physics, or a related field. * Experience: Minimum 2 years of hands-on lab experience testing silicon photonics devices or related photonics/optics components. * Technical Expertise: * Strong understanding of optical integrated circuit (PIC) design, testing, and its impact on product yield and performance. * Hands-on experience with optical test and measurement equipment (e.g., optical spectrum analyzers, power meters, interferometers, high-speed photodetectors) and optomechanical alignment tools. * Proficiency in Python for test automation, data analysis, and instrument control. * Knowledge of automated wafer-level testing (WLT) and test methodologies for silicon photonics. Practical experience in WLT is highly preferred. * Experience with fiber alignment automation or active alignment techniques. * Problem-Solving: Strong analytical and troubleshooting skills, with the ability to resolve complex system issues and propose corrective actions. * Communication & Collaboration: * Strong verbal and written communication skills to effectively convey complex test results, analysis, and technical insights. * Ability to work cross-functionally with design, manufacturing, and packaging teams. * Work Ethic & Adaptability: * Highly self-motivated and capable of managing multiple tasks with attention to detail. * Comfortable working in a fast-paced environment with evolving technical challenges. Benefits Package: * Competitive base salary and meaningful equity package. * Comprehensive health benefits (Medical, Dental, Vision). * Unlimited PTO and paid company holidays. * Team events and company meetups. * Complimentary lunch provided daily at our NYC office Equal Opportunity Employer Voyant Photonics is an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and do not discriminate based on race, color, religion, gender, gender identity or expression, sexual orientation, pregnancy, marital or partnership status, age, national origin, citizenship, veteran or military status, disability, medical condition, genetic information, caregiver status, or any other characteristic protected by law.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. S/he will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation including proto-type design and fabrication and data generation through designed experiments. The Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data, • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 4+ years of product development experience is required., • A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is highly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Working knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Experience with IDE and PMA submissions., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $80,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred., • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables., • Experience in the medical device/ (GxP) industry is required., • Validation (IQ, OQ, PQ) or PPAP (Production Part Approval Process) required, • Must have knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Benefits: The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc... Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job DescriptionCompany Description At Butterfly Network, we're leading a digital revolution in medical imaging, transforming an industry that has long relied on bulky, analog systems. With our proprietary Ultrasound-on-Chip™ technology, we're democratizing healthcare by shifting ultrasound from the expensive, stationary systems of the past to the connected, mobile, and software-enabled platforms of today. In 2018, we launched the world's first handheld, whole-body ultrasound, Butterfly iQ – followed by iQ+ in 2020 and iQ3 in 2024, each more powerful than the last. Our innovation doesn't stop at hardware. Butterfly combines our advanced device with intelligent software, AI, services, and education to drive adoption of affordable, accessible imaging. Our technology is proving to help clinicians, clinics, and hospitals enhance care, cut costs, and expand imaging access. We've been recognized by Prix Galien USA, Fierce 50, TIME's Best Inventions, Fast Company's World Changing Ideas, among other awards. We're a team of bold thinkers, problem-solvers, and innovators ready to shape the future of medical imaging. Let's build something extraordinary together! Job Description You will be working in Butterfly's fast-growing Information Security (InfoSec) team to better meet the needs of our customers in the global healthcare sector. As a Security Engineer, you will have the opportunity to work closely with our DevOps, Hardware, Software, AI, Risk Management, Audit, Quality Team, and Cloud Engineering Teams to secure our product and our cloud security architecture. As we scale our business internationally and into large enterprises, security has never been more important to our company and those patients we help every day. Manage, Monitor, and Maintain Global Security Certifications rooted in National Institute of Standards and Technology (NIST) - International Organization for Standardization (ISO) - Health Information Technology for Economic and Clinical Health (HITECH) - International Electrotechnical Commission (IEC). As part of our team, your core responsibilities will be: • Assess, triage, and prioritize security alerts from logging and monitoring systems., • Incident response management and breach mitigation., • Conduct vulnerability assessment, determine deviations from acceptable configurations, and assess the level of risk; recommend appropriate mitigation countermeasures., • Work in collaboration with IT, Cloud Operations, and Engineering Teams to secure our AWS environment., • Keep abreast of tools, techniques, and process improvements in support of security detection and analysis in accordance with current and emerging threat and attack vectors., • Support digital forensic activities including collecting, processing, preserve, analyze, and present evidence in support of vulnerability mitigation, and investigations., • Help mature and maintain an Incident Response Program., • Develop playbooks, work instructions, process flow, Risk Assessments, and automation solutions., • Evidence and artifact collection and articulation for purpose of Audit and Accreditations., • Supports Routine Governance and Control Meetings (e,g. Security Steering Committee, etc.), • Performs Third Party Risk Management of a selection of vendors via automated tool (e.g. VisoTrust)., • Writing and maintaining a robust portfolio of prescribed Information Security Policies and Procedures., • Management of the Annual and Intermittent Security Training Curriculum (working with the Learning Management System (LMS) Admin., • Lead the administration Information Security Committee, • Lead the administration of the BC/DR/IR Plans and Testing, • Manage and Submit routine Con-Mon Reports to issue certification authorities., • Management of the Routine User Access Reviews and validation approvals., • Partnership with Internal/External Auditors on Statement of Compliance (SOC-2), ISO27001, C5 Germany, NHS DSPT England, GovRAMP, TX-RAMP, FedRAMP, HITRUST., • Contributes to Executive Presentations of the InfoSec state and environment., • Will require working nights (at times), weekends (at times), or holidays (at times) on a rotational basis with the rest of the team to ensure 24x7 coverage., • Supports our CISO in additional security initiatives and projects, as needed. Qualifications • Baseline skills/experiences/attributes:, • Minimum 7+ years of cybersecurity experience, 2 of which include being in a Security Operation Center (SOC)/Computer Security Incident Response Team (CSIRT) environment., • Experience investigating cybersecurity events and incidents using a full suite of alerting and response tools, digital forensic or malware analysis tools., • Firsthand experience with Vulnerability Management preferably Rapid7, perform scans, produce reports, and track remediation., • Experience managing User Access Reviews, to ensure access, proper roles, and findings are accurate and timely., • Strong familiarity with NIST 800-53 (Rev-5)., • Strong familiarity with ISO27001., • Strong Project Management skills (PMP, Six Sigma, or Agile)., • Strong Audit Coordination Skills (interpretation, artifact collection, and mapping)., • Skilled in Plan of Action & Milestones (POA&M), • Skilled in Continuous Compliance Monitoring (Con-Mon), • Strong written and communications skills (collaborating with employees at all levels)., • CISSP, GIAC, and or AWS Certified Security Specialty a plus. Values Innovation is what we do. Our values are how we make it happen. Butterflies are and believe in… • Patient-Centric Innovators: Our mission is THE mission., • Empowered to Impact: Every voice matters., • One Team, One Goal: Unity fuels progress., • Growth Champions: We embrace challenges. This is a hybrid position and will be based out of our office in New York City Office two to three days every week. Benefits and Perks • Comprehensive health insurance, encompassing dental and vision coverage, is provided to all our employees. As a health-tech company, we prioritize the well-being of our teams. Additionally, employees have the option to buy up for enhanced health insurance coverage. We also contribute to Health Savings Account (HSA) accounts for all enrolled employees on an annual basis., • Comprehensive Employee Assistance Program - we provide access to tools and resources to support your emotional health and day-to-day needs., • 401k plan and match - we facilitate your retirement goals., • Eligible employees will have the opportunity to participate in Employee Stock Purchase Plan (ESPP), • Unlimited Paid Time Off + 10 Holiday Days a Year - recharge and come back ready to make an impact, • Parental Leave - we aim to provide our employees with time to bond with their growing family, along with additional support for primary caregivers to help transition back to work, • Competitive salaried compensation - we value our employees and show it, • Equity - we want every employee to be a stakeholder, • The opportunity to build a revolutionary healthcare product and save millions of lives! Compensation Our estimated salary for this role based in NYC is around $100,000 base + bonus + equity + benefits. Actual pay is determined by multiple factors such as skills, qualifications, experience and market demand. For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status. Butterfly Network does not accept agency resumes. Butterfly Network is an E-Verify Company. Butterfly Network is an equal opportunity employer. Regardless of race, traits associated with race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines. Butterfly requires security adherence responsibilities from all employees. These include: adhering to all company security policies and procedures, utilize provided company assets securely, and complete all required security awareness training programs. Safeguarding company data and systems from unauthorized access, modification, or destruction, contributing to the overall security posture of the organization. Immediately reporting any suspected or actual security incidents, including phishing attempts, malware infections, or unauthorized access, following the established incident response procedures. #LI-KG #KG-LI

Job Description We are seeking a detail-oriented and experienced Validation Engineer to join our Quality team. In this role, you will take the lead in validating equipment, software, and manufacturing processes to ensure compliance with internal procedures, FDA/ISO standards, and customer requirements. You will play a key role in developing validation strategies, executing protocols, and supporting continuous improvement initiatives in a fast-paced, highly regulated medical device manufacturing environment. What You’ll Do • Lead validation projects for CNC, robotic, and other manufacturing equipment., • Develop and execute validation documentation, including:, • Validation Master Plans (VMP), • User Requirement Specifications (URS), • Installation Qualification (IQ), • Operational Qualification (OQ), • Performance Qualification (PQ), • Conduct risk assessments, validation reviews, and change control activities., • Collaborate with cross-functional teams, customers, and suppliers to align on validation requirements., • Support continuous improvement and Lean initiatives to optimize equipment performance and reduce waste., • Maintain up-to-date knowledge of GMP, ISO 13485, and validation best practices., • Education: BS in Mechanical Engineering or related field (Master’s preferred)., • Experience: Minimum 3 years in validation engineering, with hands-on experience writing and executing IQ/OQ/PQ protocols., • Background in highly regulated industries; medical device experience and ISO 13485 exposure strongly preferred., • Familiarity with CNC and robotic manufacturing processes., • Strong understanding of measurement system analysis (e.g., Gage R&R) and statistical tools (MiniTab preferred)., • Knowledge of GMP, Lean, and Six Sigma (Green/Black Belt certification is a plus)., • Excellent communication skills with the ability to work across departments and with customers., • Be part of a company dedicated to producing high-quality orthopedic medical devices., • Work on cutting-edge machine validation projects with opportunities for growth and advancement., • Collaborative and supportive team environment. Work Location: Multiple locations Company DescriptionPhillips Precision, Inc. has been providing a long-term, rewarding career path in Medical Manufacturing for Over 50 Years. Medical manufacturing provides many benefits - including a stable industry, competitive salaries, hands-on access to the latest technologies and the pride of knowing that you're working on real, tangible products that improve the health and well-being of people young and old. We have a diverse multicultural staff with varied backgrounds which brings a broad spectrum of new ideas and perspectives. We also maintain a manufacturing culture of continuous improvements with LEAN manufacturing disciples. This means we work smart, and efficiently with the ability to create custom solutions for the customers we serve. Medical Manufacturing at Phillips Precision is exciting and rewarding, with access to the latest technology and a supportive workplace environment.Phillips Precision, Inc. has been providing a long-term, rewarding career path in Medical Manufacturing for Over 50 Years.\r\n\r\nMedical manufacturing provides many benefits - including a stable industry, competitive salaries, hands-on access to the latest technologies and the pride of knowing that you're working on real, tangible products that improve the health and well-being of people young and old.\r\n\r\nWe have a diverse multicultural staff with varied backgrounds which brings a broad spectrum of new ideas and perspectives. We also maintain a manufacturing culture of continuous improvements with LEAN manufacturing disciples. This means we work smart, and efficiently with the ability to create custom solutions for the customers we serve.\r\n\r\nMedical Manufacturing at Phillips Precision is exciting and rewarding, with access to the latest technology and a supportive workplace environment.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionDescriptionPrecision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life. Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS. As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals. We are seeking a Senior Mechanical Engineer to join our Implant Hardware team to design scalable solutions to chronically implanted electronics. This position will best suit someone who is experienced with mechanical design of Class III medical devices with implantable electronics such as IPG, DBS, spinal cord stimulator, cochlear implants, etc. This is an extraordinary opportunity to join our core team to help shape the future of our company. Your work will see commercialization quickly so that we improve the lives of patients who live with neurological disorders in a matter of months and years, not decades. This position is on-site at our Manhattan office. To be eligible for this role, you must currently be based in the United States, and have working rights. Key Responsibilities • Execute hands-on design, testing, and process development tasks for mechanical packaging of implantable electronic components., • Complete hands-on assembly, integration and testing tasks while ensuring rigorous quality control is being enforced., • Collaborate with the rest of our team to publish and present our work., • BS/MS in Mechanical Engineering (ME), Biomedical Engineering (BME) or similar., • 5+ years of industry experience in mechanical engineering roles, preferably in the medical device industry., • Experience designing parts for CNC, injection molding, 3D printing, and die stamping manufacturing techniques., • Experience designing class III medical devices with implantable electronics, • Experience with medical leads, connectors, and feedthroughs., • Experience designing, evaluating, and debugging hermetic seals, laser welded/brazed joints, and thick film metalization., • Experience with compression molding, liquid injection molding, or overmolding, • Excellent organizational and communication skills; able to collaborate with neuroscientists, neurosurgeons, and electrical, software, materials, and bio engineers., • Expert in CAD (we use SolidWorks) and finite element analysis FEA, • Track record of working towards accelerated timelines.

Job DescriptionAbout RadformationRadformation is transforming the way cancer clinics deliver care. Our innovative software automates and standardizes radiation oncology workflows, enabling clinicians to plan and deliver treatments faster, safer, and more consistently, so patients everywhere can receive the same high-quality care. Our software focuses on three key areas:• Time savings through automation• Error reduction through automated systems• Increased quality care through advanced algorithms and workflows We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every conversation with our customers brings us closer to ensuring no patient’s treatment quality depends on where they live. Job BriefWe are looking for a highly motivated QA Automation Engineer with a passion for software quality and test automation. In this dynamic, fast-paced role, you will work directly with Product Managers, QA Managers, and the engineering team to ensure our products meet the utmost quality standards through efficient automated testing. You will use your strong software engineering background to design and implement automated tests that identify bugs and issues early in the development lifecycle as well as develop final validation testing prior to release. You will play a key role in shaping our test automation and reducing our reliance on manual testing. This role requires a solid understanding of software testing best practices and an ability to operate in a regulated software environment. Many of our products are SaMD medical devices, so you will ensure that testing provides products that are high quality, supporting patient safety and regulatory compliance. With your technical expertise, you’ll improve the efficiency of our testing process - helping expedite release cycles through automations - and enhance the reliability of our software for both clinicians and patients. This role offers opportunities for continuous learning and the chance to make a meaningful impact by delivering reliable, high-quality software. Responsibilities Include• Design and implement test automation frameworks from the ground up by identifying areas of manual testing that can be automated• Create scalable test scripts for regression, functional, and UI testing• Coordinate with Product to ensure testing considerations are integrated from requirements through release• Develop and execute automated tests for each product version prior to release (Python, C#, Java, or similar)• Troubleshoot and debug test failures, working with Product and Engineering to isolate root causes• Incorporate incoming customer-reported issues into automated test coverage• Generate and maintain documentation for test plans, test cases, and automated test results• Evaluate, integrate, and maintain automation tools (applications, scripts, dashboards) to increase QA team efficiency• Create and maintain controlled test environments to catch issues early and enable reliable product deployment• Work with Product and Regulatory teams to ensure verification and validation (V&V) activities are documented for compliance Required Experience• 5+ years in software test automation or software engineering in test• Hands-on verification and validation (V&V) experience• Programming automated testing in Python, C#, Java, or similar• Experience with automation frameworks/tools (e.g., Katalon, Ranorex, WinAppDriver, FlaUI, SmartBear TestComplete, Cypress)• Strong problem-solving and critical thinking skills• Clear communication and collaboration with cross-functional teams• Ability to multitask and work independently in a fast-paced environment• Detail-oriented documentation of test plans, cases, and results Preferred Experience• Lead or senior QA automation engineer experience across multiple products• Familiarity with FDA Class IIa+ regulated medical device software• Building automation frameworks and integrating CI/CD pipelines• Testing SaaS, cloud, and/or web applications at scale, including performance• Agile development experience (acceptance criteria and deliverables)• Domain knowledge in healthcare software, preferably radiation oncology• Experience with Jira, Visual Studio, Matrix ALM, or similar tools Who You Are• Quick learner, eager to adopt new tools and technologies• Thrives in a dynamic, multi-product environment• Motivated by providing timely deliverables• Strong organizational skills and clear communicator• Independent, proactive, and collaborative team player• Analytical and detail-oriented in test design and execution• Motivated to improve software quality and positively impact end users• Open mindset and receptive to ideas and feedback AI & Hiring IntegrityAt Radformation we believe in getting to know the real you. We ask that all interviews and assessments be completed without tools that generate answers in real time, to help ensure a fair and authentic hiring process. Benefits & Perks — What Makes Us RADWe care about our people as much as we care about our mission. The base salary range for this role is $100,000 – $160,000 USD (for US-based employees), commensurate with degree, title, and experience. Salary range will vary for Canada-based candidates. Benefits include:• High-quality medical plan options with premiums covered for employees (subsidized for dependents)• Health coverage starting on day one, plus short- and long-term disability and life insurance• 401(k) with immediate employer match• Annual reimbursement for professional development• Self-managed PTO, 10 paid holidays, monthly internet stipend, and home office setup allowance• Fully remote work environment with virtual events and yearly retreats Our Commitment to DiversityCancer affects people from every walk of life, and we believe our team should reflect that diversity. Radformation is proud to be an equal opportunity employer and we are committed to fostering an inclusive environment where all employees feel supported and valued. Agency & Candidate Safety NoticeRadformation does not accept unsolicited resumes from agencies without a signed agreement in place. All legitimate communication from Radformation will come from an @radformation.com email address. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Job Title: Sr. Manufacturing Engineer with Medical Device Location: Jersey City, NJ (Onsite) Duration: 12+ Months Job Description: In this role, you will be supporting a large Medical Device/Diagnostic company and working on a project focused on a design transfer of a manufacturing line and duplicating a multi part complex manufacturing process in a new location. They will be responsible for setting up and building brand new cutting edge equipment and becoming the SME for the pieces of equipment on the manufacturing line. Day to day: • Define precise specifications for new equipment and packaging components, aligning manufacturing capabilities with marketing objectives., • Apply your expertise in engineering principles and financial acumen to enhance diagnostic manufacturing performance, champion cost reductions, and achieve the highest levels of quality and efficiency., • Ensuring that automated equipment /systems installed in production areas function according to specifications and are fully prepared for qualification activities and hand-off to production., • Reducing equipment downtime, decreasing mean time to repair & improving throughput yield, • Plans and manages project activities for projects within filling and packaging manufacturing streams. Defines specifications for new equipment and packaging components in accordance with manufacturing capabilities and marketing objectives. Apply engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions and achieve optimum level of quality and efficiency., • Establish New Equipment and Processes - Uses technical and business knowledge and expertise to support Operations in the design, maintenance, installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aids in the preparation of user requirements, bid package, capital justification, and acceptance testing strategy for all new filling, packaging and manufacturing equipment., • Manufacturing Documentation - Creation of a variety of documentation used to support product launches and manufacturing, including but not limited to filling records, packaging records, manufacturing records, packaging development purchasing specifications and SOP’s. Initiate and oversee change requests and design change requests as needed. Required Experience: • Bachelor’s Degree in Engineering related to Mechanical or Chemical Engineering, • Experience working hands in a cGMP environment 6+ years, • Working hands on with automated filling and packaging equipment, • Experience with surface treatment (i.e. plasma, CO2 cleaning), adhesive bonding, drying methods and micro dispensing preferred., • Experience with injection molding of primary packaging components preferred, • Experience managing projects in a matrixed organization., • Experience with design transfer activities for medical devices preferred., • Experience implementing automation equipment preferred., • Material Science knowledge is a plus., • A self-starter who has the ability and self-awareness to understand the company’s goals and project scope, enabling them to perform at a high level under minimal supervision and add value to the organization. Company DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and rolesHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments.\r\n\r\nWe serve Government agencies, Fortune 500 and leading mid-market companies across every Industry\r\nOur candidate network includes thousands in our database and targeted networks including top social sites\r\nWe gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates\r\n\r\nOur cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent\r\nWe can provide experienced IT Professionals for your IT Projects covering most Technologies and roles

Job Description Job Title: Project Engineer Company: PTI Tech Location: Clifton, NJ (On-site) Industry: Manufacturing / Metal & Plastic Injection Molding Experience Level: Mid to Senior Level About PTI Tech PTI Tech is a leading provider of advanced manufacturing solutions, specializing in precision metal and plastic injection molding for the aerospace, medical device, industrial, and defense industries. We are growing our technical team and seeking a skilled and motivated Project Engineer to support innovative product and process development efforts. Position Summary PTI Tech has an immediate opening for a Project Engineer to support the design and development of new products, components, and advanced manufacturing processes. This position plays a key role in PTI’s R&D and production programs, working closely with the Engineering Manager and cross-functional teams. Responsibilities include initial concept design, 3D modeling, analysis, prototyping, process development, vendor coordination, and supporting the implementation of novel engineering solutions. The ideal candidate is passionate about mechanical design, manufacturing innovation, and automation. We’re looking for a hands-on engineer with strong problem-solving skills, project leadership experience, and the ability to work effectively in a fast-paced, team-oriented environment. Key Responsibilities Design & Development • Develop production processes, tooling, fixtures, and manufacturing cells with a focus on quality and repeatability., • Perform technical and requirements analysis, researching new materials, technologies, and processes., • Apply DFM to assess part moldability and recommend design improvements for injection molding (plastic, metal, ceramic)., • Lead engineering projects from concept through production, coordinating cross-functional teams and external partners., • Create and manage project timelines, task assignments, and deliverables., • Write detailed work instructions, set up manufacturing equipment, and establish standard operating procedures (SOPs)., • Design and implement automation processes to increase manufacturing efficiency and consistency., • Program and troubleshoot Universal Robots and Arburg robotic systems., • Design and develop custom end-of-arm tooling for robotic automation., • Integrate automation systems into production workflows and support new product introductions (NPIs)., • Support ongoing production by resolving technical issues and improving part quality., • BS or MS in Mechanical Engineering, Materials Science, or related field., • Proficiency in CAD design using SolidWorks., • 5+ years of experience in mechanical design and development of injection-molded or over-molded parts and assemblies., • Strong knowledge of DFM, injection molding (plastic/metal), tool and mold design, and automation integration., • Experience with machine shop processes: turning, milling, EDM, and CNC machining., • Fluent in interpreting engineering drawings and applying GD&T., • Strong project management and organizational skills., • Experience in aerospace, medical device, defense, or industrial sectors., • Familiarity with additive manufacturing., • Experience with process validation, lean manufacturing, and quality systems., • Program management experience is a plus. Company DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job Description Hi, I'm Bobby, the Chief Commercial Officer (CCO) at EnsoData! We're excited to announce that we're looking to grow the sales team - Account Executives who are self starters and want to help us grow our business of making healthcare better. This remote position offers the following compensation: • Base salary: $90,000, • At plan: $220,000, • New hire guarantees for the first six months, • Bonus potential after annual target is reached, • Uncapped commissions, • Stock options The person in this role will work for our East Coast Regional Sales Director (RSD), Jon Anderson, and will be focused on growing the EnsoSleep HST solution to all sleep, and referring physicians. This person needs to be professional and knowledgable in the business of sleep and medical devices. Here is a little about what we are doing in the world of sleep medicine... EnsoSleep - FDA-Cleared PSG and HSAT Scoring and Study Management EnsoSleep PPG - FDA-Cleared, AI-Powered Sleep Diagnosis Using Pulse Oximeters **Here is a link to learn a little about our Celeste app! Reporting to the RSD, this person will have the following responsibilities to name a few: • Strive to exceed the monthly revenue quota, • Identify prospective customers, generate and convert leads to sales; collaborate with new and existing customers to identify needs and sell solutions, • Coordinate the sales process with marketing and the Sales Engineer (demonstrations), • Negotiate contracts and pricing with the RSD and/or CCO, • Maintain their customer details in our CRM, HubSpot, • Partner with Marketing and others to develop and refine sales and marketing strategies, • Travel to shows to represent EnsoData and, as needed, travel for onsite demonstrations EnsoData EnsoData strives to make healthcare more accurate, efficient, and affordable through waveform artificial intelligence (AI) technology. Using AI and machine learning, our software analyzes billions of data points collected from sensors placed throughout the human body. Our first solution, EnsoSleep, reduces the time clinicians spend analyzing, scoring and managing sleep studies. This results in a simplified and accelerated patient testing, diagnosis, and treatment workflow. Our AI-powered technology has the capability of informing health decisions beyond sleep medicine, from monitoring patient health in the ICU or through wearables, to detecting and capturing seizure data, to providing earlier detection of heart disease, diabetes, stroke, and Alzheimer’s. Requirements This is what we need in our new team member: • Previous experience in sleep medicine, specifically home sleep testing sales (PPG is preferred), • Healthcare Software as Medical Device, SaaS or healthcare software sales knowledge preferred, • Clinical aptitude, business acumen & strong work ethic, • Hunter mindset w/ creative thinking, • Preferred 5+ years account executive experience, • Experience closing business in a health system required, • Enterprise health system sales experience preferred, • Experience working with CRM, preferred but not required, • Bachelor's degree is preferred, • Excellent people skills and positive attitude, ability to partner with a dynamic team, • Experience working with remote and hybrid office/remote teams, • Previous experience at a startup, tech, software engineering, or similar company is a bonus, • Desire to contribute to building groundbreaking technologies to make healthcare more efficient, affordable, and effective, • Personal qualities of integrity, perseverance, and commitment to the mission, • Ability to travel up to 75% of the time Company Culture - Embrace the Pineapple! How do we do this? • Make Healthcare Better - is passionate about moving healthcare to a better place for everyone everywhere, • Put Customers First - delights customers by working closely with them to support their initiatives, • Be a Great Teammate - spreads the good vibes and is a joy to work with; also understands the value of helping one's teammates, • Gets $#!t Done - bias toward action and intrinsically motivated to go above and beyond; demonstrates the ability to work autonomously as well as across teams, • We also practice a Focus on Quality and look for teammates who don't cut corners and demonstrate integrity and attention to detail Benefits The benefits package includes, but is not limited to, the following: Remote and flexible schedule - we are a remote company with hybrid options and support for flexible schedules! That being said, we have an amazing office headquarters in downtown Madison, WI with views of the capitol that you are welcome to work at anytime. In case you didn't know, Madison has consistently been ranked as one of the top places to live in the US (businessinsider.com, money.com, livability.com)! Health, dental, and vision insurance with options to choose a plan that fits you and your dependents needs. Paid time off options - we want our employees to rest, recharge, and feel better. Stock options - we want team members to feel ownership in the organization. When EnsoData does well, you do well. 401k to help people invest in the future. Team Summits! We look forward to opportunities to gather in person and enjoy a few days together. We participate in team events and gain some great in-person time. (Hint: check out our blog for info from former team gatherings!) Interview Process • Submit a resume online and our hiring team will choose those that seem like the best candidates., • We look forward to meeting you face-to-face! A few candidates will be chosen for a video call to get to know each other, discuss your experience, and explain the position in more detail., • Expect an opportunity to demonstrate your skills., • The final candidates will have a chance to meet a few people from the team. EnsoData seeks to recruit, hire, and retain the most talented people from a diverse candidate pool. Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women and other marginalized folks tend to only apply when they check every box. If you think you’re a great fit, but don't necessarily check every box on the job description, please still get in touch. To learn more about our ongoing commitment to diversity, check here. Note: this role is based in the continental United States and currently EnsoData is unable to support sponsorships so candidates must be legally eligible to work and reside in the United States now and in the future. Equal Employment Opportunity EnsoData is proud to be an Equal Employment Opportunity employer. We do not discriminate against, nor do we tolerate unlawful harassment against, team members or any other covered persons on any basis of race, color, protective hairstyles, national, social, or ethnic origin, gender, pregnancy, childbirth, gender orientation, identity or expression, sexual, relationship, or romantic orientation, marital, civil union or domestic partnership status, family or parental status, age, protected veteran status, arrest record, expunged or sealed convictions, criminal history, source of income, credit history, housing status, physical, mental, or sensory disability, medical condition, genetic information, religion, or any other status protected by the laws or regulations in the locations where we operate. We value, celebrate, and support diversity, inclusion, and our differences. We are committed to providing a safe work environment and a company culture of mutual respect where equal employment opportunities are available to all applicants and teammates. We seek to recruit, hire, and retain the most talented people from a diverse candidate pool. We strongly encourage women, people of color, LGBTQIA+ individuals, people with disabilities, members of ethnic minorities, intersectional individuals, foreign-born residents, and veterans to apply. We have a deep conviction that diversity and inclusion among our teams, our communities, and our physical and virtual workplaces is vital to the success of EnsoData’s mission to improve healthcare access, outcomes, and affordability for patients and communities everywhere globally. If you are a job seeker applying to EnsoData and you feel that you need to request an accommodation or alternative application, please contact Angela at . The applicant tracking system used to collect candidate resumes has artificial intelligence features built into it which may or may not be used during candidate recruitment and selection.

Certified Quality Engineer(CQE) and Medical device, particularly Orthopedic industry, experience preferred.

Certified Quality Engineer(CQE) and Medical device, particularly Orthopedic industry, experience preferred.

Job DescriptionBioDigital is searching for a Strategic Account Director to manage and expand enterprise accounts, working closely with cross-functional teams to ensure clients fully utilize their cloud-based, interactive 3D human body visualization platform and realize its value in enhancing health education and understanding. This role requires a strong background in SaaS and/or healthcare sales, excellent communication and collaboration skills, and a passion for making healthcare accessible to everyone. Who we areBioDigital has built the first cloud-based solution for visualizing the human body in interactive 3D. Like Google Earth for the human body, our cutting-edge technology empowers patients, educators, and professionals worldwide with an engaging, visual way to learn about health and medicine. Our team is on a mission to make health and the human body understandable to all, and we’re seeking a talented, customer-centric Strategic Account Director to help execute on our ambitious goals. Who you areIdeally, you'll have a proven track record in selling and managing cloud-based software solutions, particularly within healthcare, life sciences, or medical technology. You are skillful and passionate about developing and managing high-value, complex client relationships by deeply understanding their needs, proactively identifying opportunities to expand business within the account, and collaborating cross-functionally to deliver strategic solutions that align with the client's long-term goals. You enjoy collaboration with sales, product, content, and customer success teams to help clients realize the value of our platform. You are detail oriented, a creative problem solver, and have a personal connection to our mission of helping people better understand their health.What you’ll do • Own and manage a book of our largest enterprise accounts with revenue growth, renewal and retention targets., • Identify and qualify new expansion opportunities within existing accounts, proactively presenting value propositions and driving incremental revenue growth ensuring a healthy pipeline for consistent revenue growth., • Manage account renewals and proactively identify opportunities to introduce additional products and services that align with customer objectives, driving increased value., • Develop and execute strategic account plans, identifying potential growth areas, key decision-makers, and strategic initiatives, focusing on upsell and product adoption (perhaps add something like: maximize revenue and customer value)., • Proactively identify and understand evolving customer needs, challenges, and pain points, while building strong, trusted relationships with key stakeholders. Use this insight to develop tailored solutions that address their specific objectives and help achieve their business goals., • Own the overall success of the account by leading cross-functional collaboration, bringing in specialists (e.g., Account Executive, Integration Engineer, Product Manager, Science Lead, and Training/Onboarding team) as needed. Work closely with internal teams to ensure seamless execution and timely delivery of solutions., • Monitor customer satisfaction and track key account metrics, address concerns promptly, and ensure successful implementation and ongoing usage of solutions to maintain strong client relationships., • Provide accurate forecasting and account updates in CRM, maintaining detailed records of client interactions, sales stages, and follow-up activities. Provide insights to inform strategic decision-making., • Build value-based relationships with key executive level decision makers by leveraging existing client relationships and building new ones., • Represent BioDigital at industry events or trade shows.What you’ll bring to the role, • 5-10 years experience in a key account director, strategic account director or enterprise sales role., • Proven track record of achieving revenue targets and managing complex, high-value accounts within a B2B environment., • Strategic thinker with demonstrated ability to create account management plans and build trusted relationships throughout strategic accounts., • Strong analytical skills and data-driven decision-making capabilities., • Proven ability to collaborate effectively with cross-functional teams and senior leadership to achieve shared goals. Strong consultative selling skills with the ability to understand customer needs and tailor solutions accordingly., • Inquisitive by nature and interested in uncovering issues to identify business opportunities., • Detail oriented and committed to high quality deliverables., • Excellent communication, negotiation, and relationship building skills at the executive level., • Creative problem-solving attitude., • Demonstrated ability to lead teams to achieve goals without positional authority., • Experience working with B2B SaaS products and/or medical device or life sciences companies preferred., • Ability to travel up to 25% of the time for internal meetings, client meetings, trade shows and eventsThe hiring range for this position is $130,000- $140,000 base per year with the opportunity for variable compensation based on successful renewals and upsells. The actual offer may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Equal Opportunity Workplace BioDigital is committed to equal employment opportunity and to providing a work environment free of discrimination and harassment. All hiring decisions are based on business need, job requirements and individual qualifications, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, parental status, disability, gender identity or Veteran status. If you have a special need that requires accommodation, please let us know. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.