Heartflow
Principal Clinical Engineer – AI Performance & Investigations
San Francisco, California · Principal
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DOL prevailing wage, 2026-27 wage year · Bioengineers and Biomedical Engineers (17-2031) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
- Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
- As a Principal Clinical Engineer - AI Performance & Investigations, you will not handle first-line investigations.
Responsibilities
- Lead end-to-end technical investigations of products involving Heartflow's AI/ML-enabled SaMD products, including alleged accuracy issues, discrepancies with invasive or reference measurements, and software anomalies.
- Partner with Research, Software, and Systems Engineering to reproduce issues, test hypotheses, and distinguish product defects from expected performance, input limitations, and use-related factors.
- and initiate or support nonconformances, CAPAs, and risk file updates in line with ISO 14971.
- Provide expert technical input to Complaint Handling and Regulatory Affairs to support timely reportability determinations under FDA MDR (21 CFR Part 803), EU MDR vigilance, and other global requirements (e.g., PMDA).
- Identify recurring failure modes, themes, and emerging trends across investigations; escalate potential signals; and initiate or support nonconformances, CAPAs, and risk file updates in line with ISO 14971.
Nice to have
- B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline
- advanced degree (e.g., Ph.D. or clinical degree) preferred.
Skills
- Direct, hands-on experience with coronary CT, including CT angiography (CCTA), coronary plaque characterization, or atherosclerosis imaging.
- Demonstrated experience leading complex, cross-functional technical investigations through to root cause and documented conclusion.
- Comfort with data analysis to interrogate logs, outputs, and datasets and to quantify performance against expectations.
- Excellent technical writing and communication skills; track record of investigation reports that withstand regulatory review.
- Ability to communicate investigation conclusions, risks, and recommended actions clearly and concisely to executive management.
- Occasional domestic and international travel required.
- Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
- Experience investigating performance of AI/ML-enabled medical devices.
Compensation
- A reasonable estimate of the base salary compensation range is $188,000 to $240,000 per year, cash bonus, and equity. #LI-Hybrid
Benefits
- Partner with Medical and Clinical Affairs to assess clinical significance and potential patient impact, and document the clinical rationale in each escalated investigation.
- Support health hazard evaluations and field action assessments when investigations indicate a potential systemic issue.
- 12+ years of experience in medical devices and/or regulated imaging products, with substantial time in engineering, investigation, or post-market quality roles.
- Background as an R&D, Systems, or Quality Engineer, or in a clinical role, working with imaging medical devices.
Company info
- Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process.
- How You Stand Out
This listing is sourced directly from Heartflow's careers page and normalized into a canonical job model.