Principal Engineer - Product Investigations

Begell House Inc.; South San Francisco (CA); On-site; USD 188,000 - 240,000; Full time

Job summary

Heartflow is a medical technology company advancing non-invasive cardiac care with AI-driven insights. We seek a Principal Engineer to lead complex post-market investigations for our AI/ML SaMD products, collaborating across R&D, Medical, Regulatory, and Quality to identify root causes and drive corrective actions.

You will analyze case evidence, test hypotheses, and help ensure medical device regulatory compliance, including FDA and EU MDR considerations, while communicating findings clearly to

Qualifications

• S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline.
• Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
• Experience investigating performance of AI/ML-enabled medical devices.

Responsibilities

• Lead end-to-end technical investigations of Heartflow's AI/ML SaMD products, including accuracy issues and software anomalies.
• Reconstruct and analyze case-level evidence to establish root causes and drive corrective actions.
• Collaborate with R&D, Software, and Medical Affairs to reproduce issues and differentiate defects from expected performance.
• Assess clinical significance and document rationale for regulatory reports.
• Support CAPAs, nonconformances, and risk file updates per ISO 14971 and MDR requirements.

Skills

Medical devices

Regulatory reporting

MDR/Vigilance

CAPA

ISO 13485

IEC 62304

AI/ML SaMD

Root cause analysis

Technical writing

Cross-functional collaboration

Education

S. in Biomedical Engineering, Electrical Engineering, CS, Physics or related

Job description

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-an 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.

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.

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.

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.

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., 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.

• 12+ years of experience in medical devices and/or regulated imaging products, with substantial time in engineering, investigation, or post-market quality roles.
• ~ 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.

Educational Requirements & Work Experience

• S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline; Occasional domestic and international travel required.
• Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
• Experience investigating performance of AI/ML-enabled medical devices.
• Experience with risk management, including supporting health hazard evaluations and field actions.
• A reasonable estimate of the base salary compensation range is $188,000 to $240,000 per year, cash bonus, and equity.
• #We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.