Principal Device Quality Engineer

The Opportunity

As the Principal Device Quality Engineer, you will serve as the global subject matter expert (SME) for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, and compliant.

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.

Key Responsibilities

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.
• Advanced Risk Analysis: Support comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (Design and Software), specifically addressing software-driven failure modes.
• V&V Oversight: Technical lead for Software Verification and Validation (V&V); review and approve test strategies, protocols, and reports to ensure robust product performance.

Execution & Compliance

• DHF Management: Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring a seamless design transfer.
• Audit Representation: Represent the organization’s software QMS during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP).

Cross-Functional Collaboration

• Regulatory Submissions: Collaborate with Regulatory Affairs to author technical documentation for global bodies, including FDA, PMDA, and EU-MDR.
• Mentorship: Provide high-level technical guidance and training to R&D, Product and Program.

Skills Needed

• 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

Educational Requirements & Work Experience

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required; a Master’s degree is strongly preferred.
• 10+ years of experience in quality engineering or product development within the medical device industry.
• Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt.