Hiring: Principal Device Quality Engineer Company: Heartflow Location: San Francisco, CA Job Posted Time: 2026-09-10 11:19:52 Employment Type: Hybrid Target Skills & Keywords : Agile, R, Risk Management, SaaS, Six Sigma About the job Experience: •10+ years of experience in quality engineering or product development within the medical device industry. Required Skills: •As the Principal Device Quality Engineer •Your core responsibility will be overseeing compliance around the end to end design control process within the Heartflow’s Software Development Lifecycle (SDLC), advising on everything from initial architecture and security-by-design to global regulatory submissions and post-market surveillance. •Strategic Leadership •SME Guidance: Act as the primary authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45. •Modern SDLC Evolution: Lead the integration of modern technologies into the Quality Management System (QMS), specifically defining validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1). •Agile Transformation: Partner with engineering teams to implement "Compliance at Speed," applying Agile best practices while maintaining total regulatory rigor. Commit to execution to ensure predictable, complete, high quality releases. •Design Quality & Risk Management •Technical Architecture Review: Advise on software architecture through the lens of safety, security-by-design, and privacy-by-design. Qualifications: •Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required; a Master’s degree is strongly preferred. •Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt. Compensation: •$190,000 - $240,000 / year •This position has an estimated base salary of $190,000 - $240,000, bonus, and equity •This position has an estimated base salary of $190,000 - $240,000, bonus, and equity. ; #Hybrid Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!