Success in this Senior Device Quality Engineer role is defined by the ability to balance rigorous regulatory compliance with rapid Agile development. Key performance indicators include:

• Audit Readiness: Maintaining a flawless Design History File (DHF) and ensuring seamless performance during internal and external audits (FDA, MDSAP, EU-MDR).
• Release Predictability: Successfully integrating compliance into software sprints to ensure high-quality, on-time releases.
• Risk Mitigation: Effectiveness of hazard analyses and Software FMEAs in preemptively identifying safety issues.
• Regulatory Submissions: Accuracy and completion of technical documentation for global filings.
• Quality Culture: Elevating the team's compliance knowledge through effective training, coaching, and the successful adoption of safety-by-design and privacy-by-design principles across the AI/ML development pipeline.

For a Senior Device Quality Engineer at Heartflow, managing modern Software as a Medical Device (SaMD) workflows requires an integrated stack that bridges Agile development with strict regulatory compliance. Essential QMS (Quality Management System) tools—such as Greenlight Guru or MasterControl—are vital for maintaining a compliant Design History File (DHF) and automating risk management documentation like ISO 14971-compliant FMEAs. Complementing these, ALM (Application Lifecycle Management) platforms like Jira (integrated with Xray or Zephyr for traceability) are critical for managing the SDLC. These tools ensure that every sprint remains audit-ready, seamlessly linking requirements to verification testing, validation protocols, and software architecture reviews, directly supporting the "Compliance at Speed" framework required for AI-enabled medical technologies.

At Heartflow, the Senior Device Quality Engineer bridges the gap between rapid Agile development and strict medical device regulations by embedding "Compliance at Speed" directly into the Software Development Lifecycle (SDLC). Rather than viewing quality as a final hurdle, teams integrate regulatory rigor—such as IEC 62304 and ISO 14971 standards—into every Agile sprint. This approach ensures that software architecture, cybersecurity, and risk management (including FMEAs and Hazard Analysis) are addressed incrementally. By facilitating continuous design reviews and maintaining audit-ready documentation within the Design History File (DHF), the team ensures that high-velocity releases remain safe, secure, and fully compliant with global FDA and EU-MDR requirements without sacrificing development momentum.

Heartflow integrates AI/ML validation into its SDLC framework by embedding a "Compliance at Speed" approach within its Quality Management System (QMS). As a Senior Device Quality Engineer, the process involves implementing rigorous validation frameworks specifically tailored for AI/ML and cloud-based (SaaS) infrastructures. The company ensures safety-by-design by integrating regulatory standards—such as IEC 62304, ISO 14971, and ISO 81001-5-1—directly into Agile development sprints. This ensures that every software release maintains architectural integrity and cybersecurity compliance. Furthermore, the team manages comprehensive risk analysis, including Software FMEAs, and maintains audit-ready Design History Files (DHF) to document performance, ultimately bridging the gap between rapid, iterative AI development and stringent global medical device regulatory requirements.

The Senior Device Quality Engineer is instrumental to Heartflow’s regulatory strategy by serving as a subject matter expert for global submissions, including FDA (510k/De Novo) and EU-MDR. This role ensures the Design History File (DHF) remains audit-ready, maintaining the integrity of technical documentation from concept through commercialization. By integrating "Compliance at Speed" into the Agile SDLC, the engineer ensures that software architecture, AI/ML validation, and cybersecurity protocols align with international standards like IEC 62304 and ISO 14971. Ultimately, this role bridges the gap between rapid software development and the rigorous documentation requirements necessary to secure regulatory clearances, supporting Heartflow’s mission to provide safe, compliant, and cutting-edge precision heartcare solutions in global markets.