Senior Software Quality Engineer - Medical Devices

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive in Sunnyvale is seeking a Senior Quality Engineer to support product development from concept through commercialization. You will serve as a core member of the cross-functional software team, guiding software development lifecycle, design controls, risk management, and V&V activities to ensure compliant, reliable medical device software.

The role emphasizes enforcing ISO 13485 and FDA standards, collaborating with R&D, testing, regulatory affairs, and manufacturing, and driving

Qualifications

• Experience implementing software quality processes per ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, MDR.

Responsibilities

• Develop, implement, and maintain software quality processes in compliance with standards.
• Participate in design reviews, code reviews, defect tracking and software validation activities.
• Ensure adherence to SDLC processes, including Agile methodologies.

Skills

ISO 13485

SDLC & Agile

Risk management

Design controls

Regulatory submissions

Test automation

Cross-functional collaboration

Software validation

Job description

Intuitive in Sunnyvale is seeking a Senior Quality Engineer to support product development from concept through commercialization. You will serve as a core member of the cross-functional software team, guiding software development lifecycle, design controls, risk management, and V&V activities to ensure compliant, reliable medical device software.

The role emphasizes enforcing ISO 13485 and FDA standards, collaborating with R&D, testing, regulatory affairs, and manufacturing, and driving