Principal Engineer - Product Investigations

About this 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. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.

As a Principal Engineer with expertise in CT, plaque, and FFRct (Fractional Flow Reserve derived from Computed Tomography), you will be the technical lead for Heartflow's most complex product investigations arising from complaints and other sources of post-market information.

As a Principal Engineer - Product Investigations, you will not handle first-line investigations. Instead, in this unique role, you will lead and resolve escalated or complex technical investigations for Heartflow's AI/ML coronary artery disease products, including FFRct Analysis, Plaque Analysis, and PCI Navigator, partnering closely with Research, Software Engineering, Product Management, and Medical and Clinical Affairs teams. This role will report to the Director of Post-Market Quality. Your investigations and conclusions on challenging technical topics will inform regulatory reportability decisions, drive corrective actions, and feed directly back into how our products are designed and improved. If you are energized by getting to the true root cause(s) of difficult technical problems and partnering across R&D, Medical, Clinical, Regulatory, and Quality to serve patients, we want to hear from you.

Key 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.

• Reconstruct and analyze case-level evidence, including CCTA inputs, model outputs, processing logs, case analyst workflow records, and software version history, to establish robust root cause(s) 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 in each escalated investigation.

• 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.

• 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 in 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 case handling.

• 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).

• Author investigation reports that meet FDA QMSR (21 CFR Part 820) and ISO 13485 requirements and withstand scrutiny in FDA inspections, Notified Body audits, 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.

Skills Needed

• 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…