Senior 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.
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.
