Principal Device Quality Engineer

Heartflow(4 days ago)

RemoteFull TimeSenior$190,000 - $240,000Quality

About this role

The Principal Device Quality Engineer at Heartflow is the global subject matter expert for software quality and design excellence, responsible for ensuring SaMD and AI/ML-enabled solutions are safe, secure, and compliant with medical device regulations. The role bridges Agile software development and rigorous regulatory requirements across the Software Development Lifecycle, from architecture and security-by-design to regulatory submissions and post-market surveillance. This position supports global product commercialization and governance for Heartflow’s digital health offerings.

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Required Skills

Software Quality
Design Control
Risk Management
Hazard Analysis
Fault Tree
FMEA
V&V
Architecture Review
Regulatory Submissions
Agile

+6 more

Qualifications

Bachelor's Degree
Master's Degree (Preferred)
ASQ Certified Quality Engineer (CQE)
Certified Software Quality Engineer (CSQE)
Six Sigma Black Belt

About Heartflow

heartflow.com

HeartFlow, headquartered in Redwood City, California, is a health technology company that provides non-invasive coronary artery disease assessment by applying AI and computational fluid dynamics to coronary CT angiography to create patient-specific 3D models. Its flagship HeartFlow Analysis (FDA-cleared and CE-marked) quantifies blood flow and identifies flow-limiting blockages to help clinicians decide if a patient needs invasive angiography or revascularization. Deployed in hospitals and health systems globally, the platform aims to improve diagnostic accuracy, reduce unnecessary invasive procedures, shorten time to diagnosis, and lower overall costs.