Design Quality Engineer

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.

• 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.

• 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.