Senior Device Quality Engineer

Heartflow; United States; Hybrid; USD 160,000 - 180,000; Full time

Job summary

Heartflow seeks a Senior Device Quality Engineer to lead software quality within our SDLC, aligning Agile development with medical device regulations for SaMD and AI/ML technologies. You will own end-to-end design controls, risk analysis, V&V, and DHF management, ensuring audit readiness and regulatory compliance across FDA and EU submissions. Hybrid work in the U.S.

is supported. Bring 5–8 years of medical device quality experience, strong communication, and a proactive approach to risk

Qualifications

• 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.

Responsibilities

• 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 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.
• 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.
• 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

Critical thinking

Attention to detail

Communication

Documentation

Time management

Education

Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related field

Job description

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

• 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 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.
• 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.
• 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