---
title: 'Principal Clinical Engineer – AI Performance & Investigations at Heartflow'
canonical: 'https://feeny.ai/job/principal-clinical-engineer-ai-performance-investigations-heartflow-san-atfr06c6ax01'
type: 'job'
last_seen: '2026-10-19'
---

# Principal Clinical Engineer – AI Performance & Investigations at Heartflow

- **Company:** Heartflow
- **Location:** San Francisco, CA
- **Posted:** 2026-10-17
- **Last confirmed live:** 2026-10-19
- **Apply:** https://job-boards.greenhouse.io/heartflowinc/jobs/6227786004

## 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—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 Clinical Engineer – AI Performance & 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 concisely to executive management.

Educational Requirements & Work Experience

- 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.
- Occasional domestic and international travel required.

## How You Stand Out

- Experience with cardiovascular imaging, FFR/FFRct, or quantitative plaque analysis.
- Experience investigating performance of AI/ML-enabled medical devices.
- Familiarity with invasive reference standards (e.g., invasive FFR, IVUS, OCT).
- 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. #LI-Hybrid 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.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at [www.heartflow.com/about/careers/](https://www.heartflow.com/about/careers/).

## About Heartflow

## Company Overview
- **One-liner**: Heartflow is a medical technology company that leverages AI to create personalized 3D models of the heart from a single CT scan, enabling clinicians to diagnose, treat, and manage coronary artery disease (CAD) non-invasively.
- **Entity Type**: Public (NASDAQ: HTFL) – IPO in 2025
- **Headquarters**: San Francisco, California, USA
- **Founded**: 2007
- **Founders**: Not publicly listed on primary company pages; the company was founded by a team including Dr. Charles Taylor (inventor of the core technology). *Note: Founders not explicitly named on the main website.*

## Core Business
- **Primary Industry**: Medical Technology / HealthTech / AI-Driven Diagnostics (Cardiology)
- **Target Customers**: B2B – Hospitals, health systems, and cardiology clinics; the end-users are clinicians (cardiologists, radiologists) and the ultimate beneficiaries are patients with suspected or known CAD.
- **Mission/Purpose**: To transform coronary artery disease (CAD) from the leading cause of death into a disease that can be managed for life.

## Products & Services
- **Heartflow One Platform**: The company’s core AI-driven, non-invasive precision coronary care platform. It provides a suite of analyses from a single Coronary CTA (CCTA) scan:
    - **Roadmap™ Analysis**: Visualizes the coronary anatomy and assesses blood flow anywhere in the coronary tree.
    - **FFRct Analysis**: Computes Fractional Flow Reserve from CT, determining the functional significance of a blockage (the original, most established product).
    - **Plaque Analysis**: Quantifies and characterizes plaque to inform risk stratification and disease management.
    - **Type**: SaaS/Software-as-a-Medical-Device (SaMD) integrated into clinical workflow.

## Market Standing
- **Valuation/Market Cap**: Not publicly available from the provided sources. As a recently public company (2025), market cap fluctuates. *Source: LinkedIn indicates a 2025 IPO.*
- **Key Metric**: Over **650,000 patients treated**; over **1,800 institutions** using the platform; **99.5% of U.S. lives covered** for FFRct Analysis.
- **Notable Investors/Partners**: Not listed in the provided search results. The company is now public.
- **Growth Signals**:
    - Supported by scientific statements from the American College of Cardiology (ACC) and American Heart Association (AHA) for personalized CAD management.
    - Late-breaking data at AHA 2025 reinforced the prognostic power of its Plaque Analysis.
    - Growing evidence base across the CAD care continuum, from risk stratification to CT-guided intervention planning.
    - Backed by **>625 peer-reviewed publications**.
    - LinkedIn follower growth: +32% year-over-year, indicating strong brand and market interest.

## Competitive Advantages
- **First-Mover & Gold Standard in FFRct**: Heartflow created the FFRct technology category and has the most robust clinical evidence base (over 625 peer-reviewed publications) and guideline support (ACC/AHA).
- **Integrated Platform (Heartflow One)**: It is the only complete, non-invasive, precision coronary care platform that covers the entire guideline-directed CCTA pathway (anatomy, physiology, and plaque).
- **Massive Clinical & Reimbursement Moat**: Achieving 99.5% U.S. lives covered creates an enormous barrier to entry for competitors, as reimbursement and clinical adoption are already deeply established.
- **AI-First, Non-Invasive Solution**: Replaces invasive diagnostic procedures (cardiac catheterization) with a safer, cheaper, and more comfortable CT scan, aligning with the industry shift toward value-based care.

## Strategic Focus
- **Deepening the Evidence Base**: Continuing to publish clinical data to expand the use cases for its platform (e.g., from diagnosis to guiding interventions).
- **Global Expansion**: Operating in the US, Europe, and Japan, with a focus on expanding access and adoption in these key markets.
- **Platformization**: Moving from a single product (FFRct) to a comprehensive CAD management platform (Heartflow One) that manages patients from screening through treatment.
- **Lifecycle Management**: Shifting the narrative from a one-time diagnostic test to a tool for managing CAD for the patient's entire life.

## Why Work Here
- **Mission-Driven**: The work directly impacts the world's leading cause of death. The company culture emphasizes a "patient-first" mentality.
- **Remote-First Culture**: The company is remote-first with employees across the US, Europe, and Japan. Hubs include San Francisco (HQ), Austin, London, and Tokyo.
- **Strong Benefits**: Medical/Dental/Vision (90% of premium paid by company), 401k match, parental leave, flexible PTO, and an Employee Assistance Program (EAP).
- **Engineering & Clinical Excellence**: A high-caliber team of engineers, data scientists, and clinicians working on cutting-edge AI in a regulated medical environment. The tech stack involves complex 3D modeling, AI/ML, and cloud infrastructure.
- **Growth Stage**: As a recently public company with strong adoption, it offers a balance of startup energy and established market stability. High growth potential in a mission-critical field.

## Sources
1. [heartflow.com (Company Overview)](https://www.heartflow.com/)
2. [heartflow.com (About Us)](https://www.heartflow.com/about/)
3. [heartflow.com (Careers Page)](https://www.heartflow.com/about/careers/)
4. [Greenhouse (Job Board)](http://job-boards.greenhouse.io/heartflowinc)
5. [LinkedIn (Company Profile)](https://www.linkedin.com/company/heartflow-inc)

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