Senior Quality Engineer - MedTech Software & Compliance

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

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to support software development from concept to commercialization. You will ensure compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR, and guide cross-functional teams to deliver safe, reliable medical device software.

You will drive risk management, design controls, software validation, and regulatory submissions, partnering with R&D, regulatory affairs, and manufacturing.

Qualifications

• Experience with medical device standards such as 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
• Expertise with data modeling and interpretation in areas like field product performance, log analysis, reliability modeling.
• Ability to navigate quality systems with minimal oversight on individual projects.
• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
• Ability to solve complex problems with minimal oversight.
• Ability to articulate complex information to teams, including executive management

Responsibilities

• Develop, implement, and maintain software quality processes per ISO/FDA standards.
• Participate in design reviews, defect tracking, and software validation.
• Ensure SDLC adherence including Agile methodologies.
• Support risk management activities per ISO 14971 and IEC 62304.
• Collaborate with R&D and testing to identify and mitigate defects.
• Define design inputs/outputs and traceability matrices with engineering.
• Prepare submissions and respond to regulatory questions.
• Drive process improvements and implement test automation.

Skills

Quality assurance

Regulatory compliance

Risk assessment

SDLC management

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Advanced degree preferred

Tools

QA automation tools

JIRA

Git

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to support software development from concept to commercialization. You will ensure compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR, and guide cross-functional teams to deliver safe, reliable medical device software.

You will drive risk management, design controls, software validation, and regulatory submissions, partnering with R&D, regulatory affairs, and manufacturing.