As a Staff Device Quality Engineer, you will serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives. In this highly cross-functional, strategic role, you will shape quality engineering practices organization-wide, bridging 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 strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow's Software Development Lifecycle (SDLC). You will ensure that software architecture, security, and global regulatory requirements are integrated into every release, and will serve as a key decision-maker and escalation point for quality and compliance matters.
Key ResponsibilitiesTechnical Leadership & Strategy- Standards Execution: Lead the application and interpretation of evolving global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities; actively monitor regulatory landscape changes and proactively update internal practices.
- SDLC Architecture & Support: Architect and own validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS); define framework strategy and scalability roadmap across the QMS.
- Agile Integration: Define and champion "Compliance at Speed" frameworks across engineering teams, ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases; develop scalable playbooks and mentor senior engineers on quality-by-design practices.
- Quality Systems Ownership: Drive continuous improvement of the QMS, identifying systemic gaps and leading cross-functional initiatives to address them. Partner with Quality leadership to influence product strategy, roadmap prioritization, and resource planning.
Design Quality & Risk Management- Design Reviews: Lead and govern software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles across the full product portfolio; establish review criteria and approve outputs.
- Risk Analysis: Own and govern comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs; establish risk management methodology and ensure alignment across all product lines.
- V&V Strategy & Execution: Define and own the organization-wide Software Verification and Validation (V&V) strategy; develop and govern test strategies, protocols, and reports to ensure product performance, including for novel AI/ML and SaMD modalities.
Execution & Compliance- DHF Program Ownership: Define standards for and govern the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless; accountable for DHF completeness and quality across multiple concurrent programs.
- Audit Leadership: Lead and coordinate the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a primary subject matter expert for software processes; develop audit readiness programs and host regulatory agency interactions.
Cross-Functional Collaboration & Leadership- Technical Documentation: Author, review, and approve technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR; serve as the quality sign-off authority for regulatory submissions.
- Team Development & Mentorship: Provide technical coaching and quality training to R&D and Product teams to foster a culture of compliance; mentor and develop Senior and mid-level Quality Engineers, and contribute to hiring and capability planning.
- Thought Leadership: Represent Heartflow's quality and compliance perspective in industry forums, working groups (e.g., IMDRF, FDA Digital Health Center of Excellence engagement), and external partnerships relevant to SaMD and AI/ML regulation.
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.
- Demonstrated ability to influence without authority and drive alignment across engineering, regulatory, and product leadership.
- Deep expertise in quality systems strategy, including QMS architecture and CAPA program design for SaMD organizations.
Educational Requirements & Work Experience- Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
- Master's degree in a relevant technical or quality discipline preferred.
- 10+ years of experience in quality engineering or product development within the medical device industry, including at least 3 years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products.
- Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Black Belt.
This position has an estimated base salary of $165,000 - $205,000, bonus, and equity. #LI-IB1; LI-Hybrid
