Senior Design Quality Assurance Engineer
Physiol, Waltham, MA, United States
Job Details: Senior Design Quality Assurance Engineer
Key Responsibilities
Lead design assurance activities for new product development and sustaining engineering projects
Work closely with R&D (about 10 engineers) on design, testing, and verification activities
Support design reviews, verification & validation, usability testing, and Design History Files
Lead risk management activities including FMEA, risk mitigation, and effectiveness checks
Support design transfer, process validation, and test method validation
Collaborate with Regulatory, Supply Chain, Manufacturing, and Quality teams
Participate in audits, CAPA boards, and complaint review boards
Support regulatory submissions and defend design controls in internal and external audits
Track and support multiple change initiatives (~60 ongoing), including sourcing new components
Drive continuous improvement in quality and design assurance processes
Qualification
5+ years of experience in the medical device industry (Design Assurance, Quality, or Product Development)
Strong knowledge of new product development and close collaboration with R&D
Solid understanding of global regulations and standards: FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366
Experience working with cross-functional and global teams
Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
Proactive, detail-oriented, and solution-driven
Proficiency in Microsoft Office; experience with Minitab or similar tools a plus
Must be based in Boston area
Senior-level experience required
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Key Responsibilities
Lead design assurance activities for new product development and sustaining engineering projects
Work closely with R&D (about 10 engineers) on design, testing, and verification activities
Support design reviews, verification & validation, usability testing, and Design History Files
Lead risk management activities including FMEA, risk mitigation, and effectiveness checks
Support design transfer, process validation, and test method validation
Collaborate with Regulatory, Supply Chain, Manufacturing, and Quality teams
Participate in audits, CAPA boards, and complaint review boards
Support regulatory submissions and defend design controls in internal and external audits
Track and support multiple change initiatives (~60 ongoing), including sourcing new components
Drive continuous improvement in quality and design assurance processes
Qualification
5+ years of experience in the medical device industry (Design Assurance, Quality, or Product Development)
Strong knowledge of new product development and close collaboration with R&D
Solid understanding of global regulations and standards: FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366
Experience working with cross-functional and global teams
Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
Proactive, detail-oriented, and solution-driven
Proficiency in Microsoft Office; experience with Minitab or similar tools a plus
Must be based in Boston area
Senior-level experience required
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