Heartflow · 3 hours ago
Principal Device Quality Engineer
United States
Full-time
Remote
Lead/Staff
$190K/yr - $240K/yr
10+ years expHeartflow is a medical technology company focused on advancing the diagnosis and management of coronary artery disease through innovative technology. The Principal Device Quality Engineer will act as the global subject matter expert for software quality and design excellence, overseeing compliance in the software development lifecycle and ensuring regulatory adherence for digital health solutions.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
Act as the primary authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45
Lead the integration of modern technologies into the Quality Management System (QMS), specifically defining validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1)
Partner with engineering teams to implement "Compliance at Speed," applying Agile best practices while maintaining total regulatory rigor. Commit to execution to ensure predictable, complete, high quality releases
Advise on software architecture through the lens of safety, security-by-design, and privacy-by-design
Support comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (Design and Software), specifically addressing software-driven failure modes
Technical lead for Software Verification and Validation (V&V); review and approve test strategies, protocols, and reports to ensure robust product performance
Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring a seamless design transfer
Represent the organization’s software QMS during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP)
Collaborate with Regulatory Affairs to author technical documentation for global bodies, including FDA, PMDA, and EU-MDR
Provide high-level technical guidance and training to R&D, Product and Program
Qualification
Required
Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required
10+ years of experience in quality engineering or product development within the medical device industry
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
Preferred
Master's degree is strongly preferred
Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt
Benefits
Bonus
Equity
Company
Heartflow
Heartflow is a medical technology company that provides various methods of diagnosis and treatment of cardiovascular disease.
501-1000 employees
H1B Sponsorship
Heartflow has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (6)
2022 (9)
2021 (12)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$890.72MKey Investors
Bain Capital Life SciencesPanorama Point PartnersCapricorn Investment Group
2025-08-08IPO
2025-03-26Convertible Note· $98M
2023-04-06Series F· $215M
Leadership Team
John Farquhar
President and CEO
Campbell Rogers
Chief Medical Officer
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-22
GlobeNewswire
2026-01-16
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