Principal Device Quality Engineer

Heartflow is a medical technology company focused on advancing the diagnosis and management of coronary artery disease through innovative technology. The Principal Device Quality Engineer will act as the global subject matter expert for software quality and design excellence, overseeing compliance in the software development lifecycle and ensuring regulatory adherence for digital health solutions.

Responsibilities:

• Act as the primary authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45
• 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)
• 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
• Advise on software architecture through the lens of safety, security-by-design, and privacy-by-design
• Support comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (Design and Software), specifically addressing software-driven failure modes
• Technical lead for Software Verification and Validation (V&V); review and approve test strategies, protocols, and reports to ensure robust product performance
• Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring a seamless design transfer
• Represent the organization’s software QMS during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP)
• Collaborate with Regulatory Affairs to author technical documentation for global bodies, including FDA, PMDA, and EU-MDR
• Provide high-level technical guidance and training to R&D, Product and Program

Requirements:

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required
• 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
• Master's degree is strongly preferred
• Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt