Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
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 Responsibilities
Technical 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
