Senior Quality Engineer - Multiport Da Vinci Systems
Core
Senior Quality Engineer supporting the development and commercialization of next-generation robotic surgical systems (Multiport Da Vinci), ensuring design controls, risk management, and regulatory compliance.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Robotic surgical systems (cameras, instruments, accessories) for minimally invasive surgery
Domain
Medical Devices / Robotic Surgery
Required skills
Design controls, risk management (ISO 14971), process validation, FDA Design Controls, reliability testing, V&V planning, supplier qualification, regulatory audit support
Preferred skills
Reliability growth planning, limit/challenge testing execution, complex problem solving with minimal oversight
Technologies
ISO 14971, IEC 60601, IEC 62304, ISO 80002-1
Responsibilities
Contribute to design controls, risk management, and design verification/validation; Ensure reliable design transfer to manufacturing; Support regulatory submissions and internal/external audits; Partner with engineering to define design inputs/outputs and traceability matrices
Seniority
Senior, hands-on IC