Overview You will lead complex, post-market technical investigations for Heartflow's AI/ML coronary artery disease products. As a technical lead, you partner with R&D, software, medical affairs, and regulatory teams to diagnose root causes, assess patient impact, and drive corrective actions. Your work informs regulatory decisions and product improvements, shaping how Heartflow's SaMD advances clinical care. This role sits at the intersection of engineering, clinical science, and quality, offering broad influence across product design and compliance. You join a mission-driven team advancing precision heartcare at scale.
Compensation / Benefits- base salary range $188,000-$240,000
- cash bonus
- equity
- hybrid work model
- occasional domestic and international travel
Responsibilities- Lead end-to-end technical investigations of AI/ML-enabled SaMD products, including accuracy concerns and software anomalies.
- Reconstruct and analyze case evidence to establish robust root causes and preventive actions.
- Collaborate with Research, Software, and Systems Engineering to differentiate defects from performance or usage factors.
- Assess clinical significance with Medical Affairs and document clinical rationale for escalations.
- Identify recurring failure modes and initiate CAPAs and risk file updates per ISO 14971.
- Support health hazard evaluations and field action assessments for systemic issues.
- Serve as SME for regulatory inspections and cross-functional reviews.
- Develop and improve investigation methods and tools; mentor junior investigators.
- Provide expert input for regulatory reporting under MDR and QMS requirements; author investigation reports meeting FDA/ISO standards.
- Translate findings into actionable feedback for R&D and product development, ensuring verified resolution.
Key requirements- 12+ years in medical devices or regulated imaging, with engineering/investigation/post-market quality focus
- Direct experience with coronary CT, CCTA, plaque characterization, or atherosclerosis imaging
- Background as R&D, Systems, or Quality Engineer, or related clinical role in imaging devices
- Proven ability to lead complex investigations through to root cause and conclusions
- Working knowledge of MDR/vigilance, CAPA, risk management (21 CFR Parts 803 & 820, ISO 13485, ISO 14971, EU MDR)
- Experience investigating software or SaMD, with familiarity of software lifecycle and anomaly management (IEC 62304)
- Data analysis skills to interrogate logs, outputs, and datasets against expectations
- Strong written and verbal communication; ability to present to executives and regulatory bodies
- Ability to collaborate across cross-functional teams and translate technical findings to clinical impact
- excellent written communication
- cross-functional collaboration
- critical thinking
- AI/ML-enabled SaMD
- software lifecycle (IEC 62304)
- MDR and FDA regulatory knowledge
