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Salary: USD 188,000 - 240,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) that develops AI-driven solutions for diagnosing and managing coronary artery disease. The company's flagship product, HeartFlow FFR_CT Analysis, uses advanced AI to create 3D models of coronary arteries and assess blood flow impact. The product is cleared for use in the US, UK, Europe, Japan, and Canada, and has been used for over 750,000 patients worldwide.
As Principal Engineer - Product Investigations, you will serve as the technical lead for HeartFlow's most complex and escalated product investigations arising from complaints and post-market information. This is not a first-line investigation role; instead, you will lead end-to-end technical investigations of AI/ML-enabled software as a medical device (SaMD) products, including FFR_CT Analysis, Plaque Analysis, and PCI Navigator. You will partner closely with Research, Software Engineering, Product Management, Medical Affairs, and Clinical Affairs teams to resolve challenging technical problems and inform regulatory reportability decisions.
Key responsibilities include: leading technical investigations of alleged accuracy issues, software anomalies, and discrepancies with invasive or reference measurements; reconstructing and analyzing case-level evidence including CCTA inputs, model outputs, processing logs, and software version history to establish root causes; partnering with engineering teams to reproduce issues and distinguish product defects from expected performance or use-related factors; assessing clinical significance with Medical and Clinical Affairs; identifying recurring failure modes and emerging trends; supporting health hazard evaluations and field action assessments; serving as 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, 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 report to the Director of Post-Market Quality. This role requires occasional domestic and international travel.
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 software lifecycle and anomaly management (IEC 62304)
- Comfort with data analysis to interrogate logs, outputs, and datasets and quantify performance against expectations
- Ability to engage credibly with engineers and clinicians across cross-functional teams
- 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 to executive management
- B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or related technical or clinical discipline; advanced degree (Ph.D. or clinical degree) preferred
Differentiators: 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 health hazard evaluations and field actions.
