Senior (Quality Engineer 4) - Multiport Da Vinci Systems

Intuitive Surgical seeks a senior quality engineer to lead design controls, risk management, and regulatory compliance for next-generation surgical systems. The role involves guiding product development teams through design verification, manufacturing transfer, and FDA submissions across complex medical devices.

Responsibilities

• Plan and execute design controls, risk management, and design verification/validation activities
• Develop and maintain product design history and risk management files per regulatory standards
• Collaborate with engineering and manufacturing to define design inputs, outputs, and traceability
• Support design transfer to production and facilitate supplier qualification and certification
• Assist regulatory affairs with submissions and support internal/external audits

Requirements

• Minimum 8 years related experience with engineering degree, or 5 years with advanced degree
• Expertise in ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls
• Demonstrated experience with risk-based verification/validation and process validation
• Proven ability to navigate quality systems independently and manage cross-functional projects
• Strong problem-solving skills and ability to communicate complex technical information clearly
• Preferred: reliability principles, testing methodology, and V&V test execution experience