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Medical Device Design Quality Engineer

Job

VIR Healthway

Newton, MA (In Person)

Full-Time

Posted 6 weeks ago (Updated 2 weeks ago) • Actively hiring

Expires 7/1/2026

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Job Description

No C2C / Only W2 / No Sponsership Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls , risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.
Responsibilities:
Serve as Quality representative and Design Controls lead on cross-functional teams. Ensure compliance with FDA QSR (21 CFR 820.30) , ISO 13485 , MDR/MDD , and global regulations. Lead risk management per
ISO 14971
, including system-level risk analysis, FMEA/SWFMEA , and residual risk evaluation. Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V) . Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses . Support
IEC 60601-1 , IEC 60601-1-2 , IEC 80601-2-77
electrical safety/EMC compliance. Collaborate on HW/SW integration and ensure compliance with
IEC 62304/82304
. Support supplier qualification , design transfer, and DHF completeness. Contribute to IDE, De Novo, PMA submissions . Lead
CAPA , NCMR
, complaint investigations, and root cause analysis.
Qualifications:
Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences. 7-10 years' experience in Design Quality within medical devices (Class III preferred). Strong knowledge of Design Controls , QSR , ISO 13485 , ISO 14971 . Experience with Minitab or statistical analysis tools. Familiarity with ESD controls , electrical components handling. Strong technical writing, communication, and time management skills.