Senior (Quality Engineer 4) - Software/Firmware

Intuitive Surgical · Sunnyvale, CA

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Role summary

Senior Quality Engineer supporting medical device software development from concept through commercialization. Ensures compliance with regulatory standards including ISO 13485, FDA 21 CFR Part 820, and IEC 62304. Provides expertise in design controls, risk management, and software validation for cross-functional teams.

What they're looking for

8+ years related experience with university degree in computer science or engineering, or 5+ years with advanced degree
Proficiency in medical device standards: IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, FDA Design Controls
Experience with risk-based software validation, test automation, and SDLC processes
Expertise in data modeling and analysis including field performance and reliability modeling
Strong problem-solving and communication skills for technical and executive audiences
At least 2 years experience in regulated industry preferred

What you'll be doing

Develop and maintain software quality processes compliant with ISO 13485, FDA regulations, and IEC standards
Participate in design reviews, code reviews, and software validation activities across development lifecycle
Support risk management activities and collaborate on identifying and mitigating software defects
Partner with engineering on design inputs, outputs, and traceability matrix development
Drive process improvements and implement test automation strategies to enhance efficiency

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Date posted2 days ago

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