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Job Title : Senior Design Assurance Engineer – Medical Devices (DHF & Risk Focus) Location : Roseville MN Pay range : $60 - $85/hr (Negotiable) Design Assurance & Documentation • Review and enhance design documentation across the product lifecycle, including:, • Design inputs & outputs, • Requirements traceability, • Verification & validation documentation, • Ensure alignment between product requirements, risk management, and test evidence, • Support the development, update, and maintenance of Design History Files (DHF) Risk Management & Compliance • Apply risk management principles in accordance with ISO 14971, • Evaluate and align:, • Hazard analyses, • FMEA / risk files, • Risk controls and mitigations, • Ensure documentation meets FDA (21 CFR 820) and ISO 13485 standards Verification & Validation (V&V) • Review and support verification and validation activities, • Ensure test methods and protocols are:, • Scientifically sound, • Properly documented, • Traceable to requirements Quality & Post-Market Integration • Incorporate insights from:, • Complaints, • CAPA, • Field performance data, • Ensure product documentation reflects real-world performance and risk learnings Cross-Functional Collaboration • Partner with R&D, Systems Engineering, Quality, and Regulatory teams, • Participate in design reviews and cross-functional discussions, • Support project timelines, deliverables, and audit readiness Required Qualifications • Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field), • 5+ years of experience in:, • Design Assurance, • Quality Engineering, • Systems Engineering (medical devices preferred), • Strong knowledge of:, • Design controls (21 CFR 820.30), • ISO 13485, • ISO 14971 risk management, • Experience with:, • Design History Files (DHF), • Requirements traceability, • Verification & validation (V&V), • Familiarity with medical device product development in regulated environments Preferred Qualifications • Experience supporting DHF remediation or audit readiness initiatives, • Background in complex electro-mechanical or software-based systems, • Exposure to post-market quality systems (CAPA, complaints, field actions), • Strong technical writing and documentation skills Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit ___ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

We anticipate the application window for this opening will close on - 6 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Onsite We're working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. At Medtronic, we're driven by our Mission to alleviate pain, restore health, and extend life for millions of people around the world through innovative biomedical devices and connected health solutions. As our products become increasingly connected, securing the medical device ecosystem at the product and system level is critical to ensuring patient safety and product integrity. The Senior Product Security Engineer will play a key role in securing connected and embedded medical devices across the full product lifecycle. This role is focused on device/product security engineering (not enterprise IT security) and partners closely with R&D, software, systems, and quality teams to design and implement robust, scalable security controls. The ideal candidate brings hands-on experience securing embedded or IoT products in regulated environments , with strong depth in threat modeling, secure architecture, cryptography, and device-level risk management. Key Responsibilities: Product Security Engineering - Embed security requirements into the medical device development lifecycle, partnering with R&D and systems teams from architecture through release. Threat Modeling & Risk Assessment - Perform system-level threat modeling (e.g., STRIDE or similar), attack surface analysis, and vulnerability assessments for connected and embedded medical devices. Secure Architecture - Support and review implementation of device security capabilities such as: * Securebootandrootof trust * Secure firmware/software update mechanisms * Device identity and authentication * Secure communications and protocol hardening * Data protection at rest and in transit * Key management and Hardware Security Module (HSM) concepts Cryptography & Post-Quantum Readiness - Apply modern cryptographic principles and support forward-looking strategies including quantum-resistant approaches where applicable. Secure SDLC Integration - Partner with agile development teams to embed security into design reviews, code reviews, CI/CD pipelines, and verification activities. Verification & Validation - Define and support security V&V activities including penetration testing, static/dynamic analysis, fuzz testing, and vulnerability management. Standards & Compliance - Ensure alignment with medical device cybersecurity expectations including: * FDA premarket cybersecurity guidance * IEC 81001-5-1 * ISO 14971 * NIST frameworks * Relevant Medtronic quality processes Incident & Vulnerability Management - Support coordinated vulnerability disclosure, post-market monitoring, and security issue response for released products. Cross-Functional Partnership - Work closely with R&D, systems, software, quality, and regulatory teams to drive secure product development. Industry Awareness - Maintain awareness of evolving threats, healthcare cybersecurity trends, and regulatory expectations for connected medical devices. Minimum Requirements Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or related technical field and 4+ years of experience in: * Embedded/device security * IoT security * Product security engineering * OR advanced degree with 2+ years of relevant experience To Be Successful in This Role : Device/Product Security Depth - Demonstrated hands-on experience securing embedded or connected products (medical device experience strongly preferred). Threat Modeling Expertise - Practical experience performing system or device-level threat modeling and risk assessments. Embedded/IoT Security Knowledge - Strong understanding of: * Embedded systems * Firmware/software interactions * Device communications * Hardware-software security boundaries Cryptography Fundamentals - Working knowledge of: * Modern cryptographic primitives * Key management * PKI concepts * Secure protocol implementation Regulatory Awareness - Familiarity with medical device cybersecurity expectations and regulated product environments. Secure Development Practices - Experience working with agile teams and integrating security into SDLC/DevSecOps workflows. Collaboration Skills - Strong ability to influence cross-functional engineering teams. Technical Skills * Embedded or IoT security * Threat modeling methodologies (STRIDE or similar) * Secure boot / root of trust concepts * Secure firmware update mechanisms * Network and device protocol security * Cryptography and key management * Vulnerability assessment and penetration testing * Familiarity with NIST, MITRE, OWASP (device context) Preferred: * Medical device cybersecurity experience * Experience with IEC 81001-5-1 * Experience with FDA cybersecurity submissions * Background in connected healthcare products * Security certifications (Security+, CISSP, etc.) For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life-where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Medtronic benefits and compensation plans () About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here () . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here () a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will... * Build a better future, amplifying your impact on the causes that matter to you and the world * Grow a career reflective of your passion and abilities * Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here () . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email To request removal of your personal information from our systems please email

Mechanical Project Engineer - Project Leader - Fortune 500 Metals Manufacturer This Jobot Job is hosted by: Jamal Elkhateib Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $115,000 - $125,000 per year A bit about us: We are a global innovator in advanced aluminum solutions, powering progress across aerospace, automotive, commercial transportation, and industrial markets. With one of the world’s largest integrated metal manufacturing operations—spanning 100+ acres under one roof—our teams design and produce materials that make vehicles lighter, aircraft more efficient, and structures stronger, all while advancing sustainability at every step of the value chain. Why join us? • Top-notch Compensation and Benefits package, • Up to 9% total match on 401k!, • Stable Career path, • Rewarding experience to work with Fortune 500 Company, • Excellent culture and peers, • 401K Match, • 3 weeks of vacation to start Job Details Relocation Support offered* The Impact Own end-to-end capital project delivery—from scope and funding through installation, commissioning, and hand-off. You’ll spend ~95% of your time planning and executing projects with vendors and contractors, ensuring safety, quality, schedule, and budget are met in a high-performance manufacturing environment. What You’ll Do Lead full lifecycle CAPEX projects: develop scope of work, build business case and funding documentation, create project schedules, and manage budgets. Partner with procurement and legal on project language, RFQs/POs, and vendor contracts. Direct daily activities of vendors/contractors and craft personnel during installation, startup, and commissioning. Drive change control, risk mitigation, and safe work practices; ensure compliance with site standards and regulations. Coordinate cross-functionally (operations, maintenance, EHS, quality, finance) to deliver results and seamless hand-offs. Track reliability and performance, leveraging measurement and statistical controls to verify capability and sustain improvements. Basic Qualifications (Required) BS in Mechanical, Aerospace, Agricultural, Electromechanical, or Biomedical Engineering (accredited). 7+ years in a manufacturing environment. Proven track record leading, managing, and executing projects—design through installation and commissioning. Experience managing external vendors and contractors for design, materials, installation, and related services. Legally authorized to work in the U.S.; employment eligibility verification required at time of hire. No visa sponsorship available. Export Control: Role requires access to controlled technology as defined by EAR/ITAR; government authorization may be required to meet compliance obligations. Preferred Qualifications 10+ years with manufacturing processes, ideally in the metals industry. Experience developing project business cases and capital approval requests. Proficiency with reliability techniques (measurement, statistical control, capability, maintainability). Strong theoretical and hands-on problem solving to correct issues and drive sustained improvements. Ability to oversee craft personnel and maintain an ongoing, productive dialog with installers to clarify requirements and ensure safe work practices. Excellent written and verbal communication; proven success coordinating and/or leading cross-functional teams. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. 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Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired. Competence in the selection and use of Quality Engineering

Job Description Job Summary: We are seeking an experienced Principal Electrical Engineer to lead the electrical design and development of next-generation active implantable medical devices (AIMDs). This role involves architecting complex analog, digital, and mixed-signal circuits while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into manufacturable, high-performance products. Key Responsibilities: • Lead the design, development, prototyping, and testing of electrical hardware for implantable devices, including analog/mixed-signal circuits, low-power electronics, power management systems, and wireless communication interfaces (e.g., BLE, RF telemetry)., • Architect system-level electrical designs, considering implantable constraints such as ultra-low power consumption, biocompatibility, miniaturization, hermetic packaging, and long-term reliability., • Perform circuit simulation, schematic capture, PCB layout oversight, and hardware verification/validation, including ISO14708 (e.g. EMC/EMI testing)., • Conduct risk analyses (e.g., dFMEA), root cause investigations, and failure mode testing to ensure device safety and efficacy., • Collaborate with cross-functional teams (firmware, mechanical, systems, clinical, and quality engineering) to integrate electrical subsystems and support closed-loop therapies., • Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, ISO14708, and IEC 60601 series., • Mentor and provide technical guidance to junior electrical engineers; lead design reviews and contribute to strategic technology roadmaps., • Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions., • Stay current with advancements in implantable electronics, such as custom ASIC development, battery technologies, and neuromodulation systems. Qualifications: Required: • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field., • 10+ years of experience in electrical hardware design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices)., • Expertise in analog and digital circuit design, low-power mixed-signal electronics, power electronics, and control systems., • Proven track record in medical device development, including full product lifecycle from concept to commercialization., • Master's or Ph.D. in Electrical Engineering or related field., • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems., • Familiarity with ultra-low-power custom ASIC fabrication, wireless power transfer, or adaptive algorithms., • Experience and or understanding in embedded firmware design preferable, • Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits., • Excellent problem-solving and analytical skills with a focus on reliability and patient safety., • Strong communication skills for cross-functional collaboration and technical documentation., • Ability to work in a fast-paced, regulated environment with attention to detail.

Job Description Job Summary: The Senior Mechanical Engineer will lead the design and development of next-generation active implantable medical devices (AIMDS). This role involves architecting complex mechanical systems that interact with electrical systems and components while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate in a cross-functional team to translate clinical needs into manufacturable, high-performance products. Responsibilities: • Lead the design, development, prototyping, and testing of mechanical systems and components for implantable devices, including miniaturized electronics housing, hermetic enclosures, biocompatible materials, and implantable leads for signal and power delivery., • Design mechanical delivery systems and active implantable, considering implantable constraints such as miniaturization, biocompatibility, hermeticity, and long-term reliability., • Perform CAD modeling, tolerance analysis, and oversee manufacturing processes for precision components, including lead routing and strain relief design., • Conduct risk analyses (e.g., dFMEA), root cause investigations, and reliability testing to ensure device safety and efficacy., • Collaborate with cross-functional teams (electrical, firmware, systems, clinical, and quality engineering) to integrate mechanical subsystems and support closed-loop therapies., • Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, and IEC 60601 series., • Mentor and provide technical guidance to junior mechanical engineers; lead design reviews and contribute to strategic technology roadmaps., • Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions., • Stay current with advancements in implantable mechanical design, such as novel biocompatible materials, hermetic sealing technologies, and miniaturization techniques. Required Qualifications: • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field., • 7+ years of experience in mechanical design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices)., • Expertise in precision mechanical design, biocompatible materials, hermetic enclosures, miniaturization, and implantable lead design., • Proven track record in medical device development, including full product lifecycle from concept to commercialization., • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management., • Master's in Mechanical Engineering or related field. Experience with neuromodulation or cardiac rhythm management., • Familiarity with advanced manufacturing techniques, hermetic sealing, fatigue analysis, and lead insulation and connector technologies., • Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits., • Proficiency in tools such as SolidWorks, ANSYS, or similar for CAD and simulation.

Job Description Rhythm Express is seeking a creative Mechanical Design Engineer to join our product development team to design, prototype, test, and implement mechanical solutions for a next-generation wearable cardiac monitoring system. This position will work both independently and collaboratively with engineering, quality, manufacturing, and regulatory. The ideal candidate will have a bachelor’s or master’s degree in mechanical engineering, biomedical engineering, or a related field and enjoy learning and stepping into new challenges and providing state-of-the art solutions in a fast-paced environment. A strong foundation in 3D CAD design (SolidWorks preferred), design for manufacturability/assembly (DFM/DFA), and rapid prototyping is highly desirable. Experience with wearable or medical device enclosures, sealing strategies (e.g. ultrasonic welding), ISO 13485, thermal analysis, and validation testing is a plus. We are a leading provider of remote cardiac monitoring services with offices in Arden Hills, MN, Dallas, TX, and Memphis, TN. We have been named by Inc. Magazine as one of the fastest growing private companies in America for three consecutive years. Our Rhythm Express RX-1 mini is the smallest and most advanced one-piece mobile cardiac telemetry (MCT) device on the market. We offer a collaborative and inclusive work environment where personal initiative, development, and learning are highly valued. We provide excellent benefits including medical, dental, and vision coverage, pet insurance, 401(k), paid time off, and generous stock options. This is an on-site position based at our Arden Hills location. Our office is centrally located with nearby access to I-694, Snelling Ave, and I-35W. This facility includes natural light, high-efficiency filters, and UV sterilization to reduce pathogens in the air to keep employees safe.

Job Description Job Summary: The Principal Systems Engineer will lead the architecture and integration of active implantable medical devices (AIMDs). This role involves defining system-level requirements, ensuring seamless integration of electrical, mechanical, and software components, and driving compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into safe, reliable, and manufacturable products. Responsibilities: • Define and manage system-level requirements, architecture, and interfaces for implantable devices and associated external components., • Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering user system requirements and product system specifications., • Work with outside development partners to support the system design activities for development projects or programs, • Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, and system integration, etc., • Develop and maintain system models, perform trade-off analyses, and optimize constraints such as ultra-low power, biocompatibility, miniaturization, and long-term reliability, • Oversee verification and validation planning at the system level, including safety testing, • Collaborate with cross-functional teams to support design reviews, technology roadmaps, and regulatory submissions., • Stay current with advancements in implantable systems, including neuromodulation, and telemetry., • Mentor junior engineers within the engineering organization and lead technical discussions to ensure robust system design and integration. Required Qualifications: • Bachelor's degree in Systems Engineering, Electrical Engineering, Biomedical Engineering, or related field, • 10+ years of experience in system design, architecture and integration for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class II/III devices), • Proven track record in medical device development, including full product lifecycle from concept to commercialization, • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management Preferred Qualifications: • Master's or Ph.D. in Systems Engineering, Electrical Engineering or related field, • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems, • Familiarity with system modeling tools (e.g., MATLAB/Simulink), requirements management platforms, and interface control documentation, • Experience leading technical teams, design reviews, FMEA sessions., • Participation in regulatory audits

Job Description Job Title: Operations Quality Engineer Department: Quality About Us: We are a contract manufacturer offering medical device prototyping, development, and manufacturing. Our primary capabilities are balloon catheters, delivery systems, reinforced and steerable catheters, nitinol components, and biomedical textiles. Summary: The Operations Quality Engineer will work closely with customers and the manufacturing team to ensure problems that arise in Receiving Inspection (RI) and the manufacturing lines are addressed quickly, and corrective actions are implemented. A focus of the role will be on continuous improvement and mistake proofing to ensure manufacturing lines run effectively and efficiently. Assignments include resolving and trending NCMRs, customer complaints, and Supplier Corrective Actions (SCARs), completing root cause analysis, and implementing Corrective and Preventative Actions (CAPA). In addition, the Operations Quality Engineer will generate and execute process validation protocols (IQ/OQ/PQ) as well as support process risk management activities (pFMEA). Essential Duties and Responsibilities (but are not limited to): • Function as the operation’s quality customer representative when projects are transferred to manufacturing, • Supporting design transfer, verification of readiness for production, and ensuring quality requirements are fully implemented., • Lead NCMR, customer complaints and CAPA investigation and reports; including trouble shooting manufacturing problems and ensuring compliance to procedures and requirements., • Collaborate with suppliers as needed on NCMRs and SCARs, escalating to Supplier Quality Engineering when appropriate., • Participate in cross-functional teams for the review and disposition of nonconforming products or components., • Participate in cross-functional teams to develop process validation and risk management files, including IQ/OQ/PQ protocols and reports and pFMEA documentation., • Review completed Device History Record (DHR) documentation with a high degree of accuracy for Good Documentation Practices (GDP) and completeness., • Support and advise project teams on Quality Policies / Procedures (including verification, validation, statistical methods, and manufacturing controls), when necessary., • Assist in training of Special Work Orders (SWOs), Receiving Inspection Processes, and First Article Inspections (FAI) as required, • Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes., • Extensive expertise in manufacturing operations and quality systems in a medical device environment., • Understanding ISO 13485 and FDA QSR requirements including root cause analysis, risk management, and process validation., • Root Cause Analysis (RCA) includes ability to define problems, collect data, establish facts and draw valid conclusions., • ISO 13485 Lead Auditor certification preferred., • Experience in eQMS systems, preferably Grand Avenue Software (GAS)., • Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments., • Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications., • Ability to accurately prioritize and execute with minimal direction., • Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans., • Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes., • Creative problem solver coupled with good judgment., • Independent work skills., • High attention to detail and accuracy., • Ability to manage, prioritize and execute multiple tasks., • Positive, flexible outlook., • Requires a B.S. degree in Science, Engineering or Technology or associated fields., • Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971)., • Working knowledge of the application of risk management, include pFMEA and process validation., • 3-5 years’ experience in Quality Engineering., • 5+ years’ experience in the medical device industry. Catheter assembly preferred.

Job DescriptionWhy work for CVRx?CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration, and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives. A day in the life:As the Senior R&D Engineer, you will be a key member of the Research & Development team, focused on product research and design to support and improve existing devices and therapy. This role contributes to research and development projects exploring new and innovative approaches to advancing Barostim therapy. The Senior R&D Engineer also supports field and clinical activities as needed, working collaboratively across functions to help ensure successful development and evaluation efforts.Key Duties and Responsibilities: • Design, conduct, and report on pre-clinical studies as well as human feasibility studies as needed., • Analyze physiologic data and report key results., • Develop intellectual property., • Perform R&D support on both current and new product research and developmental projects. This includes identifying requirements, proposing designs, developing prototypes, as well as performing design development, testing, and verification activities as required., • Document activities in writing, including protocols, reports, memos, and change requests. Methods used are determined by approved procedures and standards., • Coordinate and/or perform analysis and troubleshooting of prototypes, products and equipment., • Coordinate prototype builds and testing with internal or external shops, labs, and animal facilities., • Interface with multiple disciplines/functional groups, including other R&D personnel, operations, quality, clinicals, regulatory, external suppliers, consultants, technical experts, and other outside resources.What we expect from you:, • Advanced degree in biomedical engineering with an emphasis on neurostimulation., • 5+ years' experience in research or as a R&D engineer in the medical device, technology, or product development environment., • Experience with basic statistics., • Solid understanding/knowledge of product development practices and procedures in the medical device industry., • Experience in establishing team goals and coordinating the activities of the team., • Self-motivated, works well with minimal supervision., • Ability to generate, evaluate, and implement new product and process concepts., • Experience working in an operating room setting., • Effective and efficient problem-solving capability., • Basic PC skills including Windows, Excel, Word, PowerPoint and MS Project.What we would like to see:, • PhD in biomedical engineering with an emphasis on neurostimulation (cardiovascular, integrative, neurophysiology preferred) or equivalent experience (7+ years) in R&D of implantable neuro stimulation devices., • Preferred specialties:, • Experience/knowledge in neural interfacing and electrode design for electrical stimulation of excitable tissue., • Computational or systems modeling of physiological responses to stimulation., • Research in the endovascular or cardiac therapy medical device industry., • Signal processing of physiological signals and associated algorithm development., • Experience/knowledge in electrochemical performance of chronically implanted electrode., • Working knowledge of process validation methods and statistical techniques., • Ability to provide work direction to other technical employees and consultants., • Ability to conduct pre-clinical studies and/or human feasibility studies.Working Conditions:, • Normal R&D laboratory and office conditions., • Occasional travel (including airline) up to 30% of the time; may include international travel.

Job Description Rhythm Express is seeking a Signal Processing AI Engineer to join our team to develop and implement machine learning algorithms used in cardiac remote monitoring. This position will work alongside and collaborate closely with engineers with expertise in signal processing, embedded systems, cloud, cybersecurity, and regulatory. The ideal candidate will graduate soon or has recently completed a bachelor's or master's degree in electrical engineering, computer engineering, computer science, biomedical engineering, or a related field and enjoys learning and stepping into new challenges. A strong foundation in signal processing, time-frequency analysis, deep learning, and machine learning is highly desirable. Experience or coursework in training models from scratch, fine-tuning pretrained models, data analysis and visualization using Python (NumPy, Pandas, Matplotlib, PyTorch/TensorFlow), data structures, algorithms, object-oriented programming, and Generative AI knowledge lookup tools is a plus. We are a leading provider of remote cardiac monitoring services with offices in Arden Hills, MN, Dallas, TX, and Memphis, TN. We have been named by Inc. Magazine as one of the fastest growing private companies in America for three consecutive years. Our Rhythm Express RX-1 mini is the smallest and most advanced one-piece mobile cardiac telemetry (MCT) device on the market. We offer a collaborative and inclusive work environment where personal initiative, development, and learning are highly valued. We provide excellent benefits including medical, dental, and vision coverage, pet insurance, 401(k), paid time off, and generous stock options. This is an on-site position based at our Arden Hills location. Our office is centrally located with nearby access to I-694, Snelling Ave, and I-35W. This facility includes natural light, high-efficiency filters, and UV sterilization to reduce pathogens in the air to keep employees safe.

Job Description How many companies can say they’ve been in business for over 177 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team! Location/Region: This position is located in Minnesota and also covering Indiana. Travel expected for training in California What’s the role? The Field Support Engineer II, with limited supervision, installs, repairs, upgrades and performs preventative maintenance on specified Carl Zeiss Meditec instrumentation in a designated field service territory. Represents Carl Zeiss Meditec at customer locations and works to achieve a high level of customer satisfaction. Responsible for all company issued property (inventory, tools, diagnostic equipment, vehicle, etc.) in accordance with company policies. Maintains a high level of professional communication with their team, customers, management, Sales and Technical Support. Sound Interesting? Here’s what you’ll do: • Diagnose and repair all designated products within an assigned service territory, including preventative maintenance, installations and upgrades per specific training, manuals and Carl Zeiss Meditec guidelines., • Schedule, create, verify and/or modify customer visits as appropriate, by assessing customers’ needs, which may include financial impact to the practice, and patients’ well being., • Complete and submit a field service report on a daily basis according to written procedures as documented in the Field Service reference database., • Complete and submit a weekly expense report according to Carl Zeiss Meditec policies and procedures., • Maintain spare parts inventory according to company guidelines and return specific spare parts as designated by policy., • Support revenue growth through the promotion and retention of service agreements., • Interface with customers in a professional, pleasant and calm demeanor., • Other duties may include, but are not limited to, instructing customers on operation and maintenance of equipment., • Maintains company-issued test equipment and support tools, including spare parts., • 0 – 3 years of previous field service experience required., • BS in Electronics, Engineering, or Computer Technology and related fields preferred., • A+ and Net+ certification preferred., • Theoretical understanding of basic electromechanical, electronic, and optical systems., • Basic understanding of troubleshooting techniques and approaches., • Must have good verbal and written communication skills., • Must have strong computer skills with the ability to obtain specific certifications as required., • Must be able to pass required training to service fine mechanics and optics. Ability to effectively service the equipment on which training is completed. Working Conditions and Special Demands: • Extensive overnight travel is required by automobile and air., • Must be able to travel in the US and internationally for training, meetings, exhibit support and coverage outside assigned territory. The FSE must be able to obtain sufficient credit to cover incurred business expenses which will be reimbursed upon expense report submission and approval., • The position requires an average of four (4) hours driving for service calls, per day. Must have a valid driver’s license and good driving record., • On occasion, must be able to lift up to 50 pounds. Thirty percent of the average workday is spent standing or walking. We have amazing benefits to support you as an employee at ZEISS! • Medical, • Vision, • Dental, • 401k Matching, • Employee Assistance Programs, • Vacation and sick pay, • The list goes on! Company DescriptionZEISS Meditec, Inc- With innovations for ophthalmology and microsurgery, ZEISS helps doctors all over the world to diagnose and treat diseases effectively.ZEISS Meditec, Inc- With innovations for ophthalmology and microsurgery, ZEISS helps doctors all over the world to diagnose and treat diseases effectively.

Job DescriptionPrincipal Electrical Engineer St. Louis Park, MN Job Summary We are seeking an experienced Principal Electrical Engineer to lead the electrical design and development of next-generation active implantable medical devices (AIMDs). This role involves architecting complex analog, digital, and mixed-signal circuits while ensuring compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross-functionally to translate clinical needs into manufacturable, high-performance products. Key Responsibilities • Lead the design, development, prototyping, and testing of electrical hardware for implantable devices, including analog/mixed-signal circuits, low-power electronics, power management systems, and wireless communication interfaces (e.g., BLE, RF telemetry)., • Architect system-level electrical designs, considering implantable constraints such as ultra-low power consumption, biocompatibility, miniaturization, hermetic packaging, and long-term reliability., • Perform circuit simulation, schematic capture, PCB layout oversight, and hardware verification/validation, including ISO14708 (e.g. EMC/EMI testing)., • Conduct risk analyses (e.g., dFMEA), root cause investigations, and failure mode testing to ensure device safety and efficacy., • Collaborate with cross-functional teams (firmware, mechanical, systems, clinical, and quality engineering) to integrate electrical subsystems and support closed-loop therapies., • Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, ISO14708, and IEC 60601 series., • Mentor and provide technical guidance to junior electrical engineers; lead design reviews and contribute to strategic technology roadmaps., • Support sustaining engineering for existing products, including troubleshooting, design improvements, and regulatory submissions., • Bachelor's degree in Electrical Engineering, Biomedical Engineering, or a related field., • 10+ years of experience in electrical hardware design for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class III devices)., • Expertise in analog and digital circuit design, low-power mixed-signal electronics, power electronics, and control systems., • Proven track record in medical device development, including full product lifecycle from concept to commercialization., • Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management.Preferred:, • Master's or Ph.D. in Electrical Engineering or related field., • Experience with neuromodulation, cardiac rhythm management, or closed-loop implantable systems., • Familiarity with ultra-low-power custom ASIC fabrication, wireless power transfer, or adaptive algorithms., • Experience and or understanding in embedded firmware design preferable, • Experience leading technical teams, design reviews, FMEA sessions, or regulatory audits., • Proficiency in tools such as Altium, SPICE simulation, MATLAB/Simulink, or similar.Skills and Competencies, • Excellent problem-solving and analytical skills with a focus on reliability and patient safety., • Strong communication skills for cross-functional collaboration and technical documentation. 6whCUYoMQq

Job DescriptionWhy work for CVRx?CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration, and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives. A day in the life:As the Senior R&D Scientist, you will be a key contributor on the Research & Development team, focused on product research and design to support and enhance CVRx’s Barostim therapy. This role partners closely with cross-functional teams to improve existing devices and to explore thoughtful, research-driven approaches to advancing the therapy. The position also provides technical support to field and clinical activities as needed, offering hands-on involvement across the product lifecycle. This is an opportunity for an experienced R&D engineer who enjoys applying scientific rigor, collaboration, and practical problem-solving to meaningful cardiovascular neuromodulation work.Key Duties and Responsibilities: • Design, conduct, and report pre-clinical studies as well as human feasibility studies as needed., • Analyze physiologic data and report key results., • Develop intellectual property., • Perform R&D support on both current and new product research and developmental projects. This includes identifying requirements, proposing designs, developing prototypes, as well as performing design development, testing, and verification activities as required., • Document activities in writing, including protocols, reports, memos, and change requests. Methods used are determined by approved procedures and standards., • Coordinate and/or perform analysis and troubleshooting of prototypes, products and equipment., • Coordinate prototype builds and testing with internal or external shops, labs, and animal facilities., • Interface with multiple disciplines/functional groups, including other R&D personnel, operations, quality, clinicals, regulatory, external suppliers, consultants, technical experts, and other outside resources.What we expect from you:, • Advanced degree in biomedical engineering with an emphasis in neurostimulation., • 5+ years' experience as a research scientist or R&D engineer in the medical device, technology, or product development environment., • Experience with basic statistics., • Solid understanding/knowledge of product development practices and procedures in the medical device industry., • Experience in establishing team goals and coordinating the activities of the team., • Self-motivated, works well with minimal supervision., • Ability to generate, evaluate and implement new product and process concepts., • Experience working in an operating room setting., • Effective and efficient problem-solving capability., • Basic PC skills including Windows, Excel, Word, PowerPoint and MS Project.What we would like to see:, • PhD in biomedical engineering with an emphasis in neurostimulation (cardiovascular, integrative, neurophysiology preferred) or equivalent experience (7+ years) in R&D of implantable neuro stimulation devices., • Preferred specialties:, • Experience/knowledge in neural interfacing and electrode design for electrical stimulation of excitable tissue., • Computational or systems modeling of physiological responses to stimulation., • Research in the endovascular or cardiac therapy medical device industry., • Signal processing of physiological signals and associated algorithm development., • Experience/knowledge in electrochemical performance of chronically implanted electrode., • Working knowledge of process validation methods and statistical techniques., • Ability to provide work direction to other technical employees and consultants., • Ability to conduct pre-clinical studies and/or human feasibility studies.Working Conditions:, • Normal R&D laboratory and office conditions., • Occasional travel (including airline) up to 30% of the time; may include international travel., • May be required to be fully vaccinated against the COVID-19 virus and other diseases.

Job Description What You’ll Do: The Design Assurance Engineer is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II reusable surgical instruments and disposable medical devices and supports the implementation and management of the digital requirements management system. This position reports to the Director of R&D Engineering. 40% Lead Design Assurance For Representation & Compliance • Represent product quality and compliance in new product development and sustaining engineering projects., • Ensure design and process controls meet regulatory and customer requirements., • Implement medical device requirements management software (Jama) to organize and effectively manage the company’s design and development files., • Create and update controlled documents (QSPs, specifications, methods) within the Quality Management System. 30% Product Testing • Develop and execute implementation, inspection, and test plans for design transfer., • Support R&D with verification/validation protocols, specifications, and reliability testing., • Coordinate external validation activities (e.g., mechanical, functional, biocompatibility, sterilization). 20% Risk Management & Reviews • Lead risk management activities (FMEA, hazard analysis, FTA, statistical analysis)., • Participate in design reviews and change control processes. 20% Technical Guidance & Design Principles • Provide technical guidance on product quality attributes., • Apply Design-to-Cost and Design-for-Manufacturability principles. The Experience, Skills and Abilities Required: • Bachelor of Science in Mechanical Engineering or Biomedical Engineering, • Minimum of 3+ years design assurance or product development., • Understanding of ISO 13485 and FDA 21 CFR 820 compliance., • Experience with full design lifecycle and phase-gate processes., • Understanding of FMEAs, DOEs and Risk Assessment methods, • Strong written and verbal skills for documentation, presentations, and team alignment., • Problem-Solving & Critical Thinking: Analytical skills to identify gaps, assess risks, and draw conclusions., • High degree of accuracy in documentation and reviews., • Working effectively in cross-functional teams (design, manufacturing, regulatory). Preferred Experience, Skills and Abilities: • Experience in medical devices, • Jama Connect requirements management software, • Minitab statistical analysis software, • Knowledge of quality methodologies (Six Sigma, DFSS, DMAIC)., • Project Management, time management, prioritization, and execution., • Leadership, mentoring, and fostering a quality culture. This position is based out of our corporate office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday. Compensation We are committed to equitable and transparent pay practices. The salary range for this position is $72,100 - $115,300, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications. Comprehensive Benefits Offerings • Medical, Dental, and Vision Insurance, • Group Life Insurance, • Short-Term Disability Insurance, • Long-Term Disability Insurance, • 401(k) Plan with Company Match, • Workers' Compensation, • Employee Assistance Program (EAP), • Regular Part-Time Benefit Eligibility, • Training and Development Program, • Tuition Assistance Program, • Paid Time Off, including:, • Holidays, • Floating Holidays, • Vacation, • Earned Sick and Safe Time (ESST)

Job Description Job Title: Software Verification Engineer Location: St. Paul, MN – Onsite – Local candidates only Period: 4 Month Contract - possibility for extensions depending on business needs and candidate performance Hours/Week: 40 hours Rate: $30-$35/hour (Hours over 40 will be paid at Time and a Half) Contract Type: W-2 (Must be Authorized to Work in the US, no sponsorships available, and no C2C/1099) Scope of Services: The Software Verification Engineer will bring testing expertise to the innovative, and fast-paced verification team. This high caliber, motivated and passionate individual will be responsible for requirements analysis, test design, test execution, defect issue resolution. Role, Responsibilities, and Deliverables: • Work independently and as a team member to plan, write, and execute test cases according to company practices, FDA regulatory, and ISO standard procedures., • Design new test suites for new features and functionality., • Perform dry runs and formal Verification activities as required., • Setup and configure Test Equipment., • Record and close defects found during V&V activities., • Perform requirements, design and tests reviews., • Configuration, installation, and deployment of software of client's workstations and laptops, • Create, update, and track issues in client's issue management system, • Provide input to documentation of product development and production procedures, • Perform quality assurance checks on issues and computer systems, • Collaborate with the software development team to document, track, maintain, and perform associated tasks as required Experience: • Bachelors degree in Computer Science, Computer, Electrical or Biomedical Engineering., • Knowledge of software testing., • Knowledge of software development lifecycle management tools., • Experience with Microsoft Windows or Linux Operating System installation and configuration, including driver troubleshooting and OS enhancements, and software installation, • Experience working with issue management systems to create, triage, and track issues, • Familiarity with performing quality assurance checks on computer systems, • Organized, on-time, quick learner and detailed oriented., • Excellent documentation skills in delivering information that adds value to managements decision-making process., • Experienced in quantitative, analytical, organizational, and follow-up skills., • Polished communicator - written documentation and oral presentations/ discussions/ meetings., • Excellent reputation for building relationships across various levels of an organization., • Energized attitude, proactive thinker and self-starter., • Experience working with high-end workstations, laptops, network hardware, internal cards like frame grabbers and external accessories like printers, monitors, touchscreens, etc., • Familiarity with OS patching, • EnSite X Mapping System experience preferred