SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: USD 160,000 - 180,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test that provides 3D models of coronary arteries to assess blood flow impact. With products cleared in the US, UK, Europe, Japan, and Canada, and used by over 500,000 patients worldwide, HeartFlow is expanding its pipeline and team.
As Senior Device Quality Engineer, you will serve as a key technical lead bridging rapid Agile development with rigorous medical device regulations. Your core responsibility is hands-on management of the end-to-end design control process within HeartFlow's Software Development Lifecycle (SDLC), ensuring software architecture, security, and global regulatory compliance are integrated into every release.
Key responsibilities include:
Technical Leadership: Apply global regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45) to daily development. Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System. Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet regulatory rigor and deliver high-quality, predictable releases.
Design Quality & Risk Management: Participate in software architecture reviews to ensure safety-by-design and privacy-by-design principles. Facilitate and document comprehensive risk management activities including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs. Lead Software Verification and Validation (V&V); develop and execute test strategies, protocols, and reports to ensure product performance.
Execution & Compliance: Manage the Design History File (DHF) from concept to commercialization, ensuring audit-ready documentation and seamless design transfer. Support internal and external audits (FDA, Notified Body, MDSAP) as a subject matter expert for software processes.
Cross-Functional Collaboration: Support Regulatory Affairs in authoring technical files for global submissions (FDA 510k/De Novo, PMDA, EU-MDR). Provide technical coaching and quality training to R&D and Product teams to foster a compliance culture.
Required: Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related technical field. 5–8 years of experience in quality engineering or product development within the medical device industry. Strong critical thinking, attention to detail, self-starter mentality, and excellent communication and documentation skills. Preferred certifications include ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.
