Responsibilities

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.
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.

Principal Device Quality Engineer at Heartflowinc · LumiJobs

Principal Device Quality Engineer

Responsibilities

Benefits

Company

Heartflowinc

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