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 ResponsibilitiesTechnical 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
