Senior Quality Engineer – Medical Device Software

Intuitive; California (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Market-competitive compensation

Equity and incentives

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to guide software quality across the product lifecycle. You will ensure compliance with ISO 13485, FDA Design Controls, and MDR while partnering with R&D, regulatory affairs, and manufacturing to deliver high-quality medical software.

The role calls for deep SDLC/Agile expertise, risk-based validation, and the ability to drive continuous improvement and test automation across cross-functional teams in a

Qualifications

• Experience with IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.
• Proven track record in risk-based software validation and SDLC processes.
• Ability to interpret data modeling and reliability analysis.
• Comfort navigating quality systems with minimal oversight.
• Strong decision-making to drive product quality and cross-functional alignment.
• Excellent communication of complex information to executives.

Responsibilities

• Develop, implement, and maintain software quality processes compliant 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 and Agile methodologies.
• Support risk management activities per ISO 14971 and related standards.
• Collaborate with R&D and testing to identify and mitigate defects.
• Ensure completeness of V&V protocols including unit/integration/system testing.
• Develop product design history files and define design inputs/outputs and traceability.
• Support regulatory submissions and audits.
• Drive process improvements and cross-functional collaboration; implement test automation.

Skills

Medical device standards

SDLC & Agile

Risk management

Problem solving

Executive communication

Quality systems navigation

Education

University degree in computer science/engineering

Advanced degree preferred

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to guide software quality across the product lifecycle. You will ensure compliance with ISO 13485, FDA Design Controls, and MDR while partnering with R&D, regulatory affairs, and manufacturing to deliver high-quality medical software.

The role calls for deep SDLC/Agile expertise, risk-based validation, and the ability to drive continuous improvement and test automation across cross-functional teams in a