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.