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Salary: USD 188,000 - 240,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) that develops AI-driven diagnostic solutions for coronary artery disease, the leading cause of death worldwide. The company's flagship product, HeartFlow FFR_CT Analysis, uses advanced AI to provide non-invasive cardiac assessment and is supported by ACC/AHA guidelines. The product suite includes RoadMap Analysis for stenosis identification, FFR_CT Analysis for coronary blood flow assessment, and Plaque Analysis for atherosclerosis characterization. HeartFlow's solutions have been used for over 750,000 patients globally and are cleared in the US, UK, Europe, Japan, and Canada.
In this Principal Clinical Engineer role, you will lead escalated and complex technical investigations into HeartFlow's AI/ML-enabled software as a medical device (SaMD) products, including FFR_CT Analysis, Plaque Analysis, and PCI Navigator. Unlike first-line investigations, you will focus on the most technically challenging cases arising from complaints and post-market information. You will report to the Director of Post-Market Quality and serve as the technical authority for resolving complex issues that inform regulatory reportability decisions, drive corrective actions, and directly influence product design improvements.
Key responsibilities include: leading end-to-end technical investigations of alleged accuracy issues, software anomalies, and discrepancies with reference measurements; reconstructing case-level evidence from CCTA inputs, model outputs, processing logs, and software version history to establish root causes; partnering with Research, Software Engineering, and Systems Engineering to reproduce issues and distinguish product defects from expected performance or use-related factors; collaborating with Medical and Clinical Affairs to assess clinical significance and patient impact; identifying recurring failure modes and emerging trends across investigations; supporting health hazard evaluations and field action assessments; serving as a subject matter expert in regulatory inspections and audits; establishing advanced investigation methods and mentoring first-line investigators; providing expert input to Complaint Handling and Regulatory Affairs for FDA MDR (21 CFR Part 803), EU MDR vigilance, and global regulatory compliance; authoring investigation reports meeting FDA QMSR and ISO 13485 requirements; and translating findings into actionable feedback for R&D and product development teams.
You will work across cross-functional teams including Research, Software Engineering, Product Management, Medical Affairs, Clinical Affairs, Regulatory Affairs, and Quality, with occasional domestic and international travel required.
**Requirements:**
- 12+ years of experience in medical devices and/or regulated imaging products, with substantial time in engineering, investigation, or post-market quality roles
- Direct, hands-on experience with coronary CT, including CT angiography (CCTA), coronary plaque characterization, or atherosclerosis imaging
- Background as an R&D, Systems, or Quality Engineer, or in a clinical role, working with imaging medical devices
- Demonstrated experience leading complex, cross-functional technical investigations through to root cause and documented conclusion
- Working knowledge of complaint handling, MDR/vigilance reporting, CAPA, and risk management requirements (21 CFR Parts 803 and 820, ISO 13485, ISO 14971, EU MDR)
- Experience investigating issues in software or SaMD products, ideally in AI/ML-based devices, with working familiarity with the software lifecycle and anomaly management (IEC 62304)
- Comfort with data analysis to interrogate logs, outputs, and datasets and to quantify performance against expectations
- Ability to engage credibly with engineers and clinicians across cross-functional teams, understanding technical details while framing findings in terms of clinical meaning
- 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
- B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline; advanced degree (Ph.D. or clinical degree) preferred
**Preferred qualifications:**
- Experience with cardiovascular imaging, FFR/FFR_CT, or quantitative plaque analysis
- Experience investigating performance of AI/ML-enabled medical devices
- Familiarity with invasive reference standards (invasive FFR, IVUS, OCT)
- Experience with risk management, including supporting health hazard evaluations and field actions
