Senior Device Quality Engineer
HeartflowMedical Diagnostics company
San Francisco Bay Area, United States$160,000 - $180,000Senior
Baillie Gifford
Bain Capital Life Sciences
Fidelity
Janus Henderson
USVP
Capricorn
Software Engineering
About the role
TL;DR
Lead software quality and design excellence for medical devices, ensuring regulatory compliance.
- •Heartflow is seeking a Senior Device Quality Engineer to lead software quality and design excellence for their AI-driven medical technology.
- •This role bridges Agile development with medical device regulations to ensure safe, secure, and compliant digital health solutions.
- •Key Responsibilities Lead end-to-end design control process within the Software Development Lifecycle (SDLC).
- •Ensure software architecture, security, and global regulatory requirements are integrated into releases.
- •Participate in software architecture reviews for safety-by-design and privacy-by-design principles.
- •Facilitate comprehensive risk management activities, including Hazard Analysis, FTA, and Software FMEAs.
- •Act as lead for Software Verification and Validation (V&V), developing and executing test strategies.
- •Requirements Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related technical field. 5-8 years of experience in quality engineering or product development in the medical device industry.
- •Strong critical thinking and attention to detail.
- •Ability to work as a self-starter in a fast-paced, adaptive environment.
Required skills
AgileRisk Management
Domain expertise
healthtech
Tech stack
Agile