Senior Quality Engineer - Medical Devices & Compliance

Intuitive; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Senior Quality Engineer to drive design controls, risk management, and lifecycle processes from early concept through commercialization. You will guide SDLC activities and ensure compliance with ISO 13485, ISO 14971, and FDA QSR while working with cross-functional teams to deliver safe, reliable medical devices.

The role emphasizes collaboration with engineering, manufacturing, and suppliers to translate user needs into robust designs and scalable manufacturing

Qualifications

• Minimum 8+ years in Quality Engineering, 4+ years in electromechanical systems or software design.
• Solid understanding of design control and risk management from concept to commercialization.
• Experience with medical standards: ISO 13485, ISO 14971, FDA QSR.

Responsibilities

• Lead design controls, risk management, and VD/VI for new products.
• Support creation of DHF and ensure compliance with internal and external standards.
• Translate user needs into design inputs and verify through validation activities.
• Collaborate across engineering, manufacturing, and supplier teams to enable scalable production.

Skills

Design controls

Risk management

Software SDLC

Regulatory compliance

Quality assurance

Education

Bachelor's degree in STEM

Job description

Intuitive Surgical is seeking a Senior Quality Engineer to drive design controls, risk management, and lifecycle processes from early concept through commercialization. You will guide SDLC activities and ensure compliance with ISO 13485, ISO 14971, and FDA QSR while working with cross-functional teams to deliver safe, reliable medical devices.

The role emphasizes collaboration with engineering, manufacturing, and suppliers to translate user needs into robust designs and scalable manufacturing