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  • Quality Specialist (Westminster)  

    Eliassen Group
    - Adams County
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    Quality Specialist CONTEXT & INITIATIVE DESCRIPTIONOur innovative Glob... Read More
    Quality Specialist CONTEXT & INITIATIVE DESCRIPTIONOur innovative Global Medical Device Client is seeking a Quality Specialist to support their Biological Safety team. This position is responsible for reviewing, revising, and strengthening cleaning validation programs for surgical instruments used in spine medical devices. The Quality Specialist will leverage strong technical expertise in cleaning validation, ISO 19227, and FDA/MDR regulations to ensure robust and compliant processes during manufacturing and vendor transfers. In performing these responsibilities, this role will work closely with business leaders, quality, regulatory, and vendor partners to assess current programs, revise acceptance criteria, and implement consistent monitoring processes that meet global regulatory expectations without invalidating existing biological safety work.DUTIES / EXPECTATIONS OF THIS ROLE.Review current cleaning validation program and provide expertise in ISO 19227 and FDA/MDR expectations.Authorize and revise procedures, protocols, and reports; justify adjustments to acceptance criteria using risk-based, science-driven rationale.Conduct risk assessments and determine appropriate validation endpoints (TOC, NVR, particulates, endotoxin).Develop and implement monitoring programs in collaboration with external vendors, ensuring consistency across suppliers.Partner cross-functionally with Quality, Regulatory, Manufacturing, and Biological Safety functions to align validation strategy.Ensure all documentation meets regulatory and audit readiness standards, supporting EU MDR and FDA requirements.Provide guidance and mentorship to internal engineers on cleaning validation best practices.Act as primary SME in discussions with auditors or regulators regarding cleaning validations. MUST HAVES QUALIFICATION SUMMARYBachelors degree in Engineering, Chemistry, or related scientific discipline.Medical Device experience is mandatory (minimum 25 years; preference for 810+ years).Direct expertise in cleaning validation for instruments in a regulated environment.Strong knowledge of ISO 19227, FDA, and MDR regulatory frameworks.Proven ability to conduct risk assessments, establish acceptance criteria, and defend decisions to auditors/regulators.Excellent communication skills with the ability to present complex technical rationales clearly to cross-functional stakeholders.NICE-TO-HAVES Chemistry background or experience with characterization of residues/contaminants. Supplier/vendor management experience.TRAVEL & LOCATION Onsite in Westminster, CO (Hybrid) Travel to different sites occasionally.START & TERMFull time permanentImmediate start

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  • Quality Specialist  

    Eliassen Group
    - Adams County
    Apply Now
    Quality Specialist CONTEXT & INITIATIVE DESCRIPTIONOur innovative Glob... Read More
    Quality Specialist CONTEXT & INITIATIVE DESCRIPTIONOur innovative Global Medical Device Client is seeking a Quality Specialist to support their Biological Safety team. This position is responsible for reviewing, revising, and strengthening cleaning validation programs for surgical instruments used in spine medical devices. The Quality Specialist will leverage strong technical expertise in cleaning validation, ISO 19227, and FDA/MDR regulations to ensure robust and compliant processes during manufacturing and vendor transfers. In performing these responsibilities, this role will work closely with business leaders, quality, regulatory, and vendor partners to assess current programs, revise acceptance criteria, and implement consistent monitoring processes that meet global regulatory expectations without invalidating existing biological safety work.DUTIES / EXPECTATIONS OF THIS ROLE.Review current cleaning validation program and provide expertise in ISO 19227 and FDA/MDR expectations.Authorize and revise procedures, protocols, and reports; justify adjustments to acceptance criteria using risk-based, science-driven rationale.Conduct risk assessments and determine appropriate validation endpoints (TOC, NVR, particulates, endotoxin).Develop and implement monitoring programs in collaboration with external vendors, ensuring consistency across suppliers.Partner cross-functionally with Quality, Regulatory, Manufacturing, and Biological Safety functions to align validation strategy.Ensure all documentation meets regulatory and audit readiness standards, supporting EU MDR and FDA requirements.Provide guidance and mentorship to internal engineers on cleaning validation best practices.Act as primary SME in discussions with auditors or regulators regarding cleaning validations. MUST HAVES – QUALIFICATION SUMMARYBachelor’s degree in Engineering, Chemistry, or related scientific discipline.Medical Device experience is mandatory (minimum 2–5 years; preference for 8–10+ years).Direct expertise in cleaning validation for instruments in a regulated environment.Strong knowledge of ISO 19227, FDA, and MDR regulatory frameworks.Proven ability to conduct risk assessments, establish acceptance criteria, and defend decisions to auditors/regulators.Excellent communication skills with the ability to present complex technical rationales clearly to cross-functional stakeholders.NICE-TO-HAVES• Chemistry background or experience with characterization of residues/contaminants.• Supplier/vendor management experience.TRAVEL & LOCATION• Onsite in Westminster, CO (Hybrid)• Travel to different sites occasionally.START & TERMFull time permanentImmediate start

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  • Senior R&D Engineer, Med Device (Sonoma)  

    Eliassen Group
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    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Senior R&D Engineer, Med Device (Fremont)  

    Eliassen Group
    - Alameda County
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Senior R&D Engineer, Med Device (San Francisco Bay Area)  

    Eliassen Group
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Senior R&D Engineer, Med Device (Alameda)  

    Eliassen Group
    - Alameda County
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Senior R&D Engineer, Med Device (San Francisco)  

    Eliassen Group
    - San Francisco County
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Director of Assessment Innovation Research (Chapel Hill)  

    Eliassen Group
    - Orange County
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    Description:Are you a dynamic and visionary leader passionate about im... Read More
    Description:Are you a dynamic and visionary leader passionate about improving child health outcomes? We are seeking a Director of Assessment Innovation Research to lead groundbreaking initiatives in physician competency assessment and pediatrician certification.Responsibilities:Collaborate with the VP of Innovation and Competency-Based Education to drive the assessment innovation agenda.Design, implement, and analyze research projects on cutting-edge assessment methodologies.Foster partnerships with academic institutions and stakeholders to advance pediatric assessment innovation.Lead the development and refinement of assessment methods and processes.Integrate emerging technologies into the existing assessment portfolio.Present and publish research findings to diverse audiences.Experience Requirements:Doctoral degree in educational/industrial psychology, sociology, measurement, or a related field.5+ years of experience in assessment research and program development in a health-related field.Expertise in psychometrics, educational measurement, and AI technologies.Strong analytical and communication skills.Visionary thinker and collaborative leader.Preferred:Experience leading cross-departmental teams and managing large projects.Knowledge of data management, quality improvement, and grant management.Education Requirements:Doctoral degree in educational/industrial psychology, sociology, measurement, or a related field.Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact InfoSec@eliassen.com. About Eliassen Group: Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate. Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Dont miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

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  • Senior R&D Engineer, Med Device (Santa Clara)  

    Eliassen Group
    - Santa Clara County
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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  • Senior R&D Engineer, Med Device (Sunnyvale)  

    Eliassen Group
    - Santa Clara County
    Apply Now
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a priv... Read More
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTIONOur client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis, cardiac conditions, lung cancer, COPD, asthma, and other pulmonary diseases. They are building a portfolio of technologies to address the needs of interventional pulmonologists and radiologists, cardiac and thoracic surgeons, and physicians who treat pulmonary disease.They are seeking a Sr. R&D Engineer Design Controls & Risk Management to support on-going development programs. This role is critical for ensuring robust design practices, regulatory compliance, and effective cross-functional collaboration throughout the product lifecycle. The position will focus on authoring/owning requirement documents, traceability matrix, and Risk Management documents, while also managing external vendor/supplier activities such as Transit/Environmental Testing, Sterilization, and Biocompatibility testing.DUTIES / EXPECTATIONS OF THIS ROLE Prepare and present structured technical documentation and summaries for internal and external stakeholders. Lead the development, documentation, and maintenance of Design Control elements including User Needs, Design Inputs/Outputs, DV protocols, test cases, and reports. Create and maintain Risk Management documentation in accordance with ISO 14971 (Design, Use-Related, Process, Software). Manage and maintain the Input/Output Trace Matrix using JAMA Software, ensuring alignment between requirements, risks, and V&V activities. Collaborate cross-functionally with R&D, Quality, Regulatory, Clinical, and Operations teams to ensure cohesive development and regulatory alignment. Participate in and/or lead formal design reviews, risk reviews, and test planning sessions. Provide input and oversight for Design Verification testing to ensure coverage of requirements and risk mitigations. Ensure compliance with applicable standards including 21 CFR Part 820, ISO 13485, and ISO 14971. MUST HAVES - QUALIFICATION SUMMARY Bachelors or advanced degree in Mechanical or Biomedical Engineering (other engineering disciplines considered with medical device experience). 5+ years of experience developing or supporting capital equipment and/or disposable medical devices (energy-based device space preferred). Proven experience authoring and managing requirements, traceability matrix, and risk documentation. Strong knowledge of Design Control and Risk Management requirements under FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971. Proficiency in authoring risk assessment documents (e.g., FMEA) and understanding risk methodologies. Strong attention to detail with a systematic approach to documentation and traceability. Excellent organizational and communication skills with the ability to manage multiple priorities.

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