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About the Role
Lead and resolve escalated or complex technical investigations for Heartflow's AI/ML coronary artery disease products, partnering closely with R&D, Medical, Clinical, Regulatory, and Quality teams to serve patients.
Responsibilities
- Lead end-to-end technical investigations of products involving Heartflow's AI/ML-enabled SaMD products.
- Reconstruct and analyze case-level evidence to establish robust root cause(s) and recommend corrective and preventive actions.
- Partner with Research, Software, and Systems Engineering to reproduce issues and test hypotheses.
- Partner with Medical and Clinical Affairs to assess clinical significance and potential patient impact.
- Identify recurring failure modes, themes, and emerging trends across investigations.
- Support health hazard evaluations and field action assessments.
- 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.
- Provide expert technical input to Complaint Handling and Regulatory Affairs to support timely reportability determinations.
- Author investigation reports that meet regulatory requirements and withstand scrutiny.
- Translate investigation findings into actionable feedback for R&D and product development teams.
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.
- Experience investigating issues in software or SaMD products, ideally in AI/ML-based devices, with working familiarity with the software lifecycle and anomaly management.
- Comfort with data analysis to interrogate logs, outputs, and datasets.
- Ability to engage credibly with engineers and clinicians across cross-functional teams.
- Excellent technical writing and communication skills.
- Ability to communicate investigation conclusions, risks, and recommended actions clearly and concisely to executive management.
Skills
- CT
- Plaque
- FFRct
- AI/ML
- Coronary artery disease
- SaMD
- CCTA
- FFRCT Analysis
- Plaque Analysis
- PCI Navigator
- ISO 14971
- FDA MDR (21 CFR Part 803)
- EU MDR
- PMDA
- FDA QMSR (21 CFR Part 820)
- ISO 13485
- IEC 62304
- Cardiovascular imaging
- FFR
- Quantitative plaque analysis
- Invasive reference standards (e.g., invasive FFR, IVUS, OCT)
- Risk management
- Health hazard evaluations
- Field actions
Location
- Remote
- Hybrid
Work Type
- Full-time
Experience Level
- Principal Engineer
Education Level
- B.S. or M.S. in Biomedical Engineering, Electrical Engineering, Computer Science, Physics, or a related technical or clinical discipline
- Advanced degree (e.g., Ph.D. or clinical degree) preferred
Salary/Compensations
- $188,000 to $240,000 per year
Benefits
- Cash bonus
- Equity
About the Company
- 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.
Equal Opportunity
- Heartflow is an Equal Opportunity Employer. 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.