Senior Quality Engineer, MedTech Software & Firmware

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a Senior Quality Engineer to guide software development from concept through commercialization, ensuring compliance, reliability, and safety of medical-device software.

You will lead quality processes per ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971, drive SDLC rigor, risk management, design reviews, and test automation across cross-functional teams.

Qualifications

• Experience with medical device software standards such as IEC 62304 and ISO 14971.
• Proficient in SDLC processes and software test automation.
• Ability to perform risk-based software validation.
• Strong problem-solving with minimal oversight.
• Experience communicating with executive management.

Responsibilities

• Develop and maintain software quality processes compliant with standards.
• Participate in design/code reviews and validation activities.
• Ensure SDLC adherence and Agile practices.
• Support risk management with ISO 14971 and related standards.
• Collaborate with R&D, testing, regulatory, manufacturing.
• Implement test automation strategies to improve efficiency.

Skills

SDLC expertise

Quality systems

Risk management

Design reviews

Regulatory compliance

Software validation

Automation testing

Education

Engineering degree (CS/biomedical/systems/electrical/mechanical)

Advanced degree in relevant fields

Job description

Intuitive Surgical, Inc. is seeking a Senior Quality Engineer to guide software development from concept through commercialization, ensuring compliance, reliability, and safety of medical-device software.

You will lead quality processes per ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971, drive SDLC rigor, risk management, design reviews, and test automation across cross-functional teams.