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 the Senior Device Quality Engineer, you will serve as a key technical lead 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 the hands-on management 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.
Key Responsibilities
Technical Leadership
- Standards Execution: Apply global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities.
- SDLC Support: Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
- Agile Integration: Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases.
Design Quality & Risk Management
- Design Reviews: Participate in software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles.
- Risk Analysis: Facilitate and document comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
- V&V Execution: Act as the lead for Software Verification and Validation (V&V); develop and execute test strategies, protocols, and reports to ensure product performance.
Execution & Compliance
- DHF Ownership: Manage the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless.
- Audit Support: Support the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a subject matter expert for software processes.
Cross-Functional Collaboration
- Technical Documentation: Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR.
- Team Guidance: Provide technical coaching and quality training to R&D and Product teams to foster a culture of compliance.
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.
- 5–8 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 Green Belt.
This position has an estimated base salary of $160,000 - $180,000, bonus. #LI-IB1; LI-Hybrid
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