HeartFlow
Principal Clinical Engineer – AI Performance & Investigations
$188K–$240K
San Francisco, California +1 · Principal · Full-time · Posted Oct 16, 2026
- Location
- San Francisco, California
San Francisco - Experience
- 12+ years; no alternatives stated.
- Education
- B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline; advanced degree preferred.
About the job
Leads complex, escalated technical investigations of HeartFlow’s AI/ML coronary imaging products, determining root causes and translating findings into regulatory decisions and product improvements.
What you'll do
- Investigate product complaints and anomalies by analyzing case evidence, reproducing issues, and documenting root causes and corrective actions.
- Partner with engineering, clinical, quality, and regulatory teams to assess patient impact, identify trends, and support reportability, CAPA, risk, and field-action decisions.
- Improve investigation methods, mentor investigators, and feed findings back to product development.
What they ask for
- 12+ years of experience in medical devices and/or regulated imaging products, including substantial engineering, investigation, or post-market quality experience.
- Hands-on coronary CT experience, such as CCTA, coronary plaque characterization, or atherosclerosis imaging.
- Demonstrated leadership of complex cross-functional technical investigations through root cause and documented conclusion.
- Working knowledge of complaint handling, MDR/vigilance, CAPA, risk management, and software/SaMD investigation requirements.
Nice to have
- Advanced degree (e.g., Ph.D. or clinical degree).
- Experience with cardiovascular imaging, FFR/FFRct, quantitative plaque analysis, AI/ML medical-device performance, invasive reference standards, or health hazard evaluations and field actions.
Pay
$188,000 to $240,000 per year (USD, base salary)
Tools
CCTA, FFRct, AI/ML, SaMD, FDA MDR (21 CFR Part 803), FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971
AI focus
Investigates performance and anomalies in AI/ML-enabled coronary artery disease products and evaluates AI-assisted investigation approaches.
Model-written summary · the original posting is authoritative