Principal Software Quality Engineer - Infrastructure/Post‑Market

What you'll do

• Lead and execute post-market software issue evaluations, including complaint analysis and risk file assessments.
• Serve as principal author of Health Risk Assessments (HRAs) for software anomalies and corrections.
• Act as a quality and compliance authority for selected software-related CAPAs, guiding root cause analysis and mitigation strategy development.
• Ensure post-market documentation is audit-ready and aligned with FDA, EU MDR, and global regulatory expectations.
• Partner closely with cross-functional teams to track metrics driving timely resolution of software issues.
• Provide technical mentorship and strategic guidance to other engineers supporting complaint handling and investigations.

What we're looking for

• 7+ years of experience in software quality, reliability engineering, or regulated medical device development.
• Strong knowledge of FDA CFR, EU MDR, ISO 13485, and IEC 62304 regulations.
• Ability to analyze software behavior, logs, and technical data for investigations.
• Excellent analytical and written/oral communication skills.
• Experience leading post-market software issue evaluations and CAPA activities.
• Capability to secure hospital credentialing for clinical site visits.
• Skilled in program management and tracking metrics across complex systems.