Principal Clinical Engineer – AI Performance & Investigations

Heartflow•San Francisco, CA

8d•Hybrid

About The Position

Heartflow is seeking a Principal Clinical Engineer to lead complex, escalated technical investigations of its AI/ML-enabled coronary artery disease products, including FFRct Analysis, Plaque Analysis, and PCI Navigator. This is not a first-line investigation role. The position partners with Research, Software Engineering, Product Management, and Medical and Clinical Affairs to determine root causes, assess clinical significance, support regulatory decisions, and inform product improvements. The role reports to the Director of Post-Market Quality. The Principal Clinical Engineer examines case-level evidence such as CCTA inputs, model outputs, processing logs, analyst workflow records, and software version history. Investigation findings may inform reportability decisions, corrective actions, risk management, health hazard evaluations, and field action assessments. The role also develops investigation methods and tools, mentors first-line Product Investigators, and communicates findings to product development teams. Heartflow is a publicly traded medical technology company focused on AI-driven, non-invasive cardiac care. Its products support the diagnosis and management of coronary artery disease and have been used for more than 750,000 patients worldwide. Occasional domestic and international travel is required.

Requirements

12+ years of experience in medical devices and/or regulated imaging products, with substantial experience 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 root cause and documented conclusion.
Working knowledge of complaint handling, MDR/vigilance reporting, CAPA, and risk management requirements, including 21 CFR Parts 803 and 820, ISO 13485, ISO 14971, and EU MDR.
Experience investigating software or SaMD products; ideally AI/ML-based devices, with working familiarity with the software lifecycle and anomaly management under IEC 62304.
Comfort with data analysis to interrogate logs, outputs, and datasets and quantify performance against expectations.
Ability to work credibly with engineers and clinicians across functions, understand technical details, and frame findings in terms of clinical meaning.
Excellent technical writing and communication skills, with 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.
Occasional domestic and international travel is required.

Nice To Haves

Advanced degree, such as a Ph.D. or clinical degree.
Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
Experience investigating performance of AI/ML-enabled medical devices.
Familiarity with invasive reference standards such as invasive FFR, IVUS, and OCT.
Experience with risk management, including supporting health hazard evaluations and field actions.

Responsibilities

Lead end-to-end technical investigations of AI/ML-enabled SaMD products, including alleged accuracy issues, discrepancies with invasive or reference measurements, and software anomalies.
Reconstruct and analyze case-level evidence, including CCTA inputs, model outputs, processing logs, case analyst workflow records, and software version history, to establish root causes and recommend corrective and preventive actions.
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.
Partner with Medical and Clinical Affairs to assess clinical significance and potential patient impact, and document the clinical rationale for each escalated investigation.
Identify recurring failure modes, themes, and emerging trends; escalate potential signals; and initiate or support nonconformances, CAPAs, and risk file updates in line with ISO 14971.
Support health hazard evaluations and field action assessments when investigations indicate a potential systemic issue.
Serve as a subject matter expert for complex technical investigations during regulatory inspections, audits, and cross-functional reviews.
Establish and improve advanced investigation methods, templates, and tools, including evaluating AI-assisted investigation approaches, and mentor first-line Product Investigators on complex cases.
Provide expert technical input to Complaint Handling and Regulatory Affairs to support timely reportability determinations under FDA MDR, EU MDR vigilance, and other global requirements such as PMDA.
Author investigation reports that meet FDA QMSR and ISO 13485 requirements and withstand regulatory and internal audits.
Translate investigation findings into actionable feedback for R&D and product development teams, including anomaly reports, requirements gaps, and product improvement recommendations, and follow through to verified resolution.