Senior Quality Engineer — Medical Devices Software & Compliance

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Sunnyvale (CA)

On-site

USD 120,000 - 180,000

Full time

2 days ago

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Job summary

Intuitive is seeking a Senior Quality Engineer to support product development from concept through commercialization as a core member of the cross-functional software team. You will provide expertise on software lifecycle, design controls, risk management, anomaly tracking, and code reviews to ensure software used in our medical devices is compliant, reliable, and safe.

You will collaborate with engineering, regulatory affairs, manufacturing, and post-market teams, drive continuous improvement

Qualifications

8+ years related experience with a university degree OR 5+ years with an advanced degree.
Experience with IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.
Experience with risk-based software validation, software test automation, and SDLC processes.
Ability to navigate quality systems with minimal oversight on individual projects.
Strong problem-solving and the ability to articulate complex information to executives.

Responsibilities

Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
Participate in design reviews, code reviews, defect tracking and software validation activities.
Ensure adherence to SDLC processes, including Agile methodologies.
Support risk management activities per ISO 14971, IEC 62304, ISO 80002-1.
Collaborate with R&D and testing to identify and mitigate software defects.
Ensure full coverage of verification and validation (V&V) protocols including unit, integration, and system testing.