HeartFlow
Principal Device Quality Engineer
$188K–$240K
San Francisco Bay Area, California, United States +1 · Principal · Full-time · Posted Aug 28, 2026
- Location
- San Francisco Bay Area, California, United States
San Francisco - Experience
- 10+ years in quality engineering or product development within the medical device industry.
- Education
- Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field; a Master’s degree is strongly preferred.
About the job
Leads software quality and design control for HeartFlow’s medical device software, including SaMD and AI/ML-enabled products, from development through regulatory submissions and post-market surveillance.
What you'll do
- Guide software quality and regulatory compliance across the SDLC, including Agile practices, QMS validation frameworks, and design controls.
- Oversee software risk analysis, verification and validation, Design History File compliance, and design transfer.
- Represent the software QMS in audits and collaborate on global regulatory documentation; mentor technical teams.
What they ask for
- Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field.
- 10+ years of experience in quality engineering or product development within the medical device industry.
- Knowledge of global medical-device software quality and regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.
Nice to have
- Master’s degree.
- ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt.
Pay
$188,000 - $240,000 USD base salary
Tools
IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, AI/ML, Cloud Infrastructure (SaaS), Cybersecurity (ISO 81001-5-1)
AI focus
Defines validation frameworks for AI/ML and supports quality and design excellence for AI/ML-enabled medical device technologies.
Model-written summary · the original posting is authoritative