Principal Clinical Engineer – AI Performance & Investigations

Heartflow•San Francisco, CA

9d•$188,000 - $240,000•Hybrid

About The Position

Heartflow is hiring a Principal Clinical Engineer – AI Performance & Investigations to lead escalated and complex technical investigations involving its AI/ML-enabled coronary artery disease software as a medical device (SaMD) products, including FFRCT Analysis, Plaque Analysis, and PCI Navigator. The role does not handle first-line investigations and reports to the Director of Post-Market Quality. It partners with Research, Software Engineering, Product Management, Medical and Clinical Affairs, and other teams to determine root causes, assess clinical significance and patient impact, support regulatory reportability decisions, drive corrective actions, and provide feedback for product design and improvement. The position involves analyzing case-level evidence such as CCTA inputs, model outputs, processing logs, analyst workflow records, and software version history. The engineer will help identify trends and potential systemic issues; support nonconformances, CAPAs, risk-file updates, health hazard evaluations, and field action assessments; and provide technical expertise during inspections, audits, and cross-functional reviews. The role also improves investigation methods and tools, mentors first-line Product Investigators, authors regulatory-ready investigation reports, and translates findings into product development recommendations through verified resolution. A B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline is required; an advanced degree such as a Ph.D. or clinical degree is preferred. Occasional domestic and international travel is required. The position is tagged #LI-Hybrid. The stated base salary range is $188,000–$240,000 per year, plus cash bonus and equity.

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, including 21 CFR Parts 803 and 820, ISO 13485, ISO 14971, and EU MDR.
Experience investigating software or SaMD product issues; working familiarity with the 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, understand technical details, and frame findings in terms of clinical meaning.
Excellent technical writing and communication skills, including a 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.
Occasional domestic and international travel 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 Heartflow 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; 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 escalated investigations.
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; mentor first-line Product Investigators on complex case handling.
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 audit scrutiny.
Translate investigation findings into actionable feedback for R&D and product development teams, including anomaly reports, requirements gaps, and product improvement recommendations; follow through to verified resolution.