Heartflow

Heartflow

Staff Device Quality Engineer

San Francisco Bay Area, California, United States · Staff+

Sponsorship not specified$165k-$205kDetected 38 days ago
Cloud PlatformsMachine LearningProduct StrategyFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationCritical ThinkingTime ManagementMentoring

About the role

  • 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.
  • Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
  • This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Responsibilities

  • Standards Execution: Lead the application and interpretation of evolving global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities
  • SDLC Architecture & Support: Architect and own validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS)
  • develop scalable playbooks and mentor senior engineers on quality-by-design practices.
  • Quality Systems Ownership: Drive continuous improvement of the QMS, identifying systemic gaps and leading cross-functional initiatives to address them.
  • Partner with Quality leadership to influence product strategy, roadmap prioritization, and resource planning.
  • Design Quality & Risk Management
  • Design Reviews: Lead and govern software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles across the full product portfolio
  • Risk Analysis: Own and govern comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs
  • V&V Strategy & Execution: Define and own the organization-wide Software Verification and Validation (V&V) strategy
  • Standards Execution: Lead the application and interpretation of evolving global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities; actively monitor regulatory landscape changes and proactively update internal practices.

Skills

  • Strong critical thinking skills and great attention to detail.
  • Ability to work as a self-starter in a fast-paced, adaptive environment.
  • Excellent communication, documentation, and time management skills.
  • Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
  • Master's degree in a relevant technical or quality discipline preferred.

Compensation

  • This position has an estimated base salary of $165,000 - $205,000, bonus, and equity. #LI-IB1; LI-Hybrid

Benefits

  • 10+ years of experience in quality engineering or product development within the medical device industry, including at least 3 years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products.
  • This position has an estimated base salary of $165,000 - $205,000, bonus, and equity. #LI-IB1; LI-Hybrid
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This listing is sourced directly from Heartflow's careers page and normalized into a canonical job model.