Senior (Quality Engineer 4) - Software/Firmware
Intuitive Surgical
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 4 days ago
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