HeartFlow
Senior Device Quality Engineer
$160K–$180K
San Francisco Bay Area, California, United States +1 · Senior · Full-time · Posted Aug 13, 2026
- Location
- San Francisco Bay Area, California, United States
San Francisco - Experience
- 5–8 years of experience in quality engineering or product development within the medical device industry.
- Education
- Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
About the job
Leads software quality and design controls across HeartFlow’s medical-device software lifecycle, ensuring SaMD and AI/ML-enabled products meet safety, security, verification, and regulatory requirements.
What you'll do
- Manage design controls and the Design History File from concept through commercialization, keeping documentation audit-ready.
- Lead software verification and validation, risk analysis, and participation in architecture reviews.
- Integrate regulatory standards into Agile development and support audits, regulatory submissions, and quality training.
What they ask for
- Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field.
- Experience in quality engineering or product development within the medical device industry.
- Strong critical thinking, attention to detail, communication, documentation, and time-management skills; ability to work independently in a fast-paced environment.
Nice to have
- ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.
Pay
USD 160,000 - 180,000 base salary
Tools
IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45, ISO 81001-5-1, SaaS, AI/ML
AI focus
Implements validation frameworks for AI/ML and supports quality and regulatory compliance for AI/ML-enabled medical-device software.
Model-written summary · the original posting is authoritative