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HeartFlow is seeking a Principal Device Quality Engineer to serve as the global subject matter expert for software quality and design excellence in medical device development. This role bridges rapid Agile development with rigorous medical device regulations, ensuring AI/ML-enabled Software as a Medical Device (SaMD) solutions are safe, secure, and compliant.
You will oversee the end-to-end design control process within HeartFlow's Software Development Lifecycle (SDLC), advising on architecture, security-by-design, regulatory submissions, and post-market surveillance. Key responsibilities include:
Strategic Leadership: Act as the primary authority on global regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45). Lead integration of modern technologies into the Quality Management System, 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 regulatory rigor.
Design Quality & Risk Management: 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. Serve as technical lead for Software Verification and Validation (V&V), reviewing and approving test strategies, protocols, and reports.
Execution & Compliance: Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring seamless design transfer. Represent the organization during internal and external audits and inspections (FDA, Notified Body, MDSAP).
Cross-Functional Collaboration: Collaborate with Regulatory Affairs to author technical documentation for global bodies (FDA, PMDA, EU-MDR). Provide high-level technical guidance and training to R&D, Product, and Program teams.
Required: Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related field; 10+ years in quality engineering or product development within medical device industry. Master's degree strongly preferred. Certifications (ASQ CQE, CSQE, or Six Sigma Black Belt) preferred.
