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← Heartflow

Principal Device Quality Engineer

Heartflow
Location
San Francisco Bay Area, California, United States
Posted
23 days ago
Department
Quality Assurance
Salary
$190,000 - $240,000
What they actually want (must-haves)
  • Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
  • 10+ years of experience in quality engineering or product development within the medical device industry
  • 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
Nice to have
  • Master’s degree is strongly preferred
  • Certifications such as ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt
What the job really is

As the Principal Device Quality Engineer at Heartflow, you will be the global subject matter expert for software quality and design excellence, ensuring compliance with medical device regulations in the development of digital health solutions. Your role involves overseeing the design control process, advising on software architecture, and leading risk management activities while collaborating with cross-functional teams on regulatory submissions and quality management system enhancements.

Benefits
  • Estimated base salary of $190,000 - $240,000
  • Bonus
  • Equity
Things to weigh
  • The role requires extensive experience in the medical device industry, which may limit candidates without this background.
  • No specific mention of remote work flexibility beyond hybrid; candidates should clarify expectations.
  • The position involves significant regulatory compliance responsibilities, which can be demanding and may require additional hours during audits or submissions.
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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