Senior Quality Engineer — Medical Device Software

Regulatory Jobs; Sunnyvale (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA, is seeking a Senior Quality Engineer to support software development from concept through commercialization. You will guide SDLC, design controls, risk management, and regulatory submissions to ensure safety and compliance of software for medical devices.

The role emphasizes cross-functional collaboration with R&D, regulatory affairs, and manufacturing. Experience with ISO 13485, FDA Design Controls, and software validation is essential.

Qualifications

• Experience with medical device development and quality systems.
• Familiarity with ISO 13485, FDA Design Controls, and IEC 62304.
• Knowledge of risk management and software validation.
• Ability to operate with limited supervision and multi-disciplinary teams.
• Strong problem-solving and communication skills.
• Ability to articulate complex information to executives.

Responsibilities

• Software QA & Compliance: develop and maintain software quality processes per ISO 13485, FDA 21 CFR 820, IEC 62304, ISO 14971, and MDR.
• Risk Management: support risk activities with internal teams and ensure V&V coverage.
• Design Control: contribute to design history file and establish traceability.
• Regulatory Support: assist with submissions and audits.
• Process Improvement & Collaboration: drive quality process improvements and implement test automation.

Job description

Intuitive Surgical in Sunnyvale, CA, is seeking a Senior Quality Engineer to support software development from concept through commercialization. You will guide SDLC, design controls, risk management, and regulatory submissions to ensure safety and compliance of software for medical devices.

The role emphasizes cross-functional collaboration with R&D, regulatory affairs, and manufacturing. Experience with ISO 13485, FDA Design Controls, and software validation is essential.