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Principal Clinical Engineer – AI Performance & Investigations

Heartflow· Quality
Apply on company site
San Francisco, CA$188k - $240kfull-timePosted 1w ago

About the role

Principal Engineer leading and resolving escalated or complex technical investigations for Heartflow's AI/ML coronary artery disease products, including FFRct Analysis, Plaque Analysis, and PCI Navigator. Reports to the Director of Post-Market Quality and partners cross-functionally to inform regulatory decisions, CAPAs, and product improvements.

Responsibilities

  • Lead end-to-end technical investigations of 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 (CCTA inputs, model outputs, logs, analyst workflow records, software version history) to establish robust root cause and corrective actions.
  • Partner with Research, Software, and Systems Engineering to reproduce issues, test hypotheses, and distinguish defects from expected performance or use-related factors.
  • Partner with Medical and Clinical Affairs to assess clinical significance and document clinical rationale for escalated investigations.
  • Identify recurring failure modes and trends; escalate signals; initiate or support nonconformances, CAPAs, and ISO 14971 risk updates.
  • Support health hazard evaluations and field action assessments for systemic issues.
  • Serve as SME for regulatory inspections, audits, and cross-functional reviews.
  • Establish and improve advanced investigation methods, templates, and AI-assisted approaches; mentor first-line investigators.
  • Provide expert input to Complaint Handling and Regulatory Affairs for FDA MDR and other global requirements; ensure timely reportability determinations.
  • Author investigation reports meeting FDA QMSR and ISO 13485 requirements and withstand audits.
  • Translate findings into actionable feedback for R&D and product development; follow through to verified resolution.

Qualifications

  • 12+ years of experience in medical devices and/or regulated imaging products, with engineering, investigation, or post-market quality background.
  • Hands-on experience with coronary CT (CCTA), plaque characterization, or atherosclerosis imaging.
  • Background as R&D, Systems, or Quality Engineer, or clinical role working with imaging medical devices.
  • Demonstrated leadership of complex cross-functional investigations through to root cause and documented conclusions.
  • Knowledge of complaint handling, MDR/vigilance reporting, CAPA, and risk management (21 CFR Part 803/820, ISO 13485, ISO 14971, EU MDR).
  • Experience investigating issues in software or SaMD, ideally AI/ML-based devices, with IEC 62304 familiarity.
  • Comfort with data analysis of logs, outputs, and datasets; ability to quantify performance.
  • Ability to communicate technical findings to engineers and clinicians, framing in clinical terms.
  • Excellent technical writing and communication; investigations that withstand regulatory review.
  • Ability to present conclusions, risks, and actions to executive management.

Skills

Required:Experience leading complex, cross-functional technical investigationsCCTA, coronary plaque characterization, or atherosclerosis imagingRegulatory quality systems knowledge (FDA MDR, EU MDR, ISO 13485, ISO 14971)

Benefits

  • cash bonus
  • equity
Last updated Oct 19, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
Company profileWebsite

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