Senior Quality Engineer - Software/Firmware

📋 Description

• Support product development from concept through commercialization; ensure software quality
• Develop and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820
• Participate in design reviews, code reviews, defect tracking, and software validation activities.
• Ensure adherence to SDLC processes, including Agile methodologies.
• Risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1.
• Implement test automation strategies to improve efficiency and coverage.

🎯 Requirements

• Experience in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and
• 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
• 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
• Ability to solve complex problems with minimal oversight and articulate complex information to

🎁 Benefits

• Vaccination disclosures may be required for certain roles; details vary by role.
• Intuitive is an Equal Opportunity Employer.
• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.