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Principal Device Quality Engineer at Heartflow - ApplyBlast

Principal Device Quality Engineer

Heartflow

9 months ago

3.0 on Glassdoor

Remote

Full Time

Senior

41 applicants

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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.

Skills

Qualifications

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

About Heartflow

heartflow.com

Headquarters

San Francisco, California, United States

Company Size

201-500 employees

Founded

2010

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Heartflow, headquartered in San Francisco, California, is a health technology company focused on transforming coronary artery disease (CAD) diagnosis and long-term management. Its AI-powered Heartflow One platform converts coronary CT angiography (CCTA) scans into detailed, patient-specific 3D models of the heart, offering tools including FFRCT Analysis for blood flow assessment, Roadmap Analysis for CAD detection, Plaque Analysis for disease quantification and risk stratification, and a PCI Navigator for intervention planning. Deployed across more than 1,800 institutions globally, Heartflow aims to improve diagnostic accuracy, personalize treatment pathways, and reduce unnecessary invasive procedures.