HeartFlow, Inc. logoHeartFlow, Inc. logo

Senior Manager of Device Quality Engineering

HeartFlow, Inc.San Francisco Bay Area, California, United States
On-site Full-time $195K/yr - $250K/yr

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Experience Level

Senior Level Manager

Qualifications

Key ResponsibilitiesDepartmental Authority: Lead as the organizational authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.QMS Roadmap: Guide the evolution of the Quality Management System (QMS), establishing a vision for validation frameworks involving AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1). People Leadership: Recruit, mentor, and develop a team of quality engineering professionals to ensure high standards and performance within the department.

About the job

About HeartFlow

HeartFlow, Inc. develops medical technology to improve the diagnosis and management of coronary artery disease. The company’s flagship HeartFlow FFRCT Analysis uses advanced AI to create non-invasive, color-coded 3D models of coronary arteries, helping clinicians understand how blockages impact blood flow. HeartFlow’s integrated heart care platform supports clinicians in identifying stenoses (RoadMap™ Analysis), assessing coronary blood flow (FFRCT Analysis), and characterizing atherosclerosis (Plaque Analysis).

HeartFlow is publicly traded (HTFL) and recognized internationally for healthcare innovation. Its solutions are approved in the US, UK, Europe, Japan, and Canada, and have supported care for over 500,000 patients worldwide.

Role Overview: Senior Manager of Device Quality Engineering

The Senior Manager of Device Quality Engineering leads the global strategy for software quality and design excellence at HeartFlow. This role builds and manages a high-performing team, connecting fast-moving Agile development with the rigorous demands of medical device regulations. The team’s work covers digital health solutions, including Software as a Medical Device (SaMD) and AI/ML technologies, with a focus on safety, security, compliance, and scalability.

Main Responsibilities

  • Direct the end-to-end design control process within the Software Development Lifecycle (SDLC).
  • Develop and implement a roadmap for compliance, security-by-design, and readiness for global regulatory requirements.
  • Mentor and develop future leaders in quality engineering.
  • Bridge Agile software development practices with medical device regulatory standards.

Location

San Francisco Bay Area, California, United States

About HeartFlow, Inc.

HeartFlow, Inc. is at the forefront of medical technology, transforming how coronary artery disease is diagnosed and managed. Our innovative solutions are recognized worldwide, making significant strides in healthcare innovation, and we are committed to improving patient outcomes.

Similar jobs

Browse all companies, explore by city & role, or SEO search pages.

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.