Senior SaMD Quality Engineer - AI/ML & Cloud, Hybrid

Heartflow is seeking a Senior Device Quality Engineer to lead end-to-end design control within the Software Development Lifecycle. You will ensure safety-by-design and privacy-by-design, bridging Agile development with medical device regulations.

You will manage the DHF, participate in design reviews, perform risk analyses, and drive V&V activities to ensure compliant, high-quality releases across global submissions. This role requires 5–8 years in medical device quality engineering.