Medical Device Design Quality Engineer

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.