Senior SaMD Quality Engineer - AI/ML, Regulatory Leader

Socket.dev; San Francisco (CA); On-site; USD 160,000 - 180,000; Full time

Job summary

Heartflow seeks a Senior Device Quality Engineer to lead end-to-end software quality within the SDLC, ensuring SaMD and AI/ML solutions are safe, secure, and regulatory-ready. You will bridge Agile development with medical device regulations and guide design transfer and audit readiness.

You will own V&V, DHF management, and regulatory submissions support, collaborating across R&D and Product teams to enforce safety-by-design and privacy-by-design principles in a fast-paced environment.

Qualifications

• Bachelor’s degree in a software/engineering field required.
• 5–8 years of experience in quality engineering or product development in medical device industry.
• Certifications (Preferred): ASQ CQE, CSQE, or Green Belt.

Responsibilities

• Apply global regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45) to daily development activities.
• Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the QMS.
• Partner with engineering teams to ensure Agile sprints meet regulatory rigor for high-quality releases.
• Participate in software architecture reviews to ensure safety-by-design and privacy-by-design principles.
• Facilitate and document risk management activities including Hazard Analysis, FTA, and Software FMEAs.
• Lead Software Verification and Validation (V&V); develop and execute test strategies and reports.

Skills

Critical thinking

Attention to detail

Communication & documentation

Education

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

Job description

Heartflow seeks a Senior Device Quality Engineer to lead end-to-end software quality within the SDLC, ensuring SaMD and AI/ML solutions are safe, secure, and regulatory-ready. You will bridge Agile development with medical device regulations and guide design transfer and audit readiness.

You will own V&V, DHF management, and regulatory submissions support, collaborating across R&D and Product teams to enforce safety-by-design and privacy-by-design principles in a fast-paced environment.