Principal SaMD Quality Engineer

Heartflowinc; San Francisco (CA); Hybrid; USD 190,000 - 240,000; Full time

Job summary

Heartflow seeks a Principal Device Quality Engineer to serve as the global SME for software quality and design excellence, bridging Agile development with medical device regulations. You will ensure safe, secure, compliant solutions, including SaMD and AI/ML-enabled tech, across the SDLC.

You will oversee end-to-end design control, advise on architecture, drive risk analysis, V&V, and DHF management, and lead regulatory submissions with a collaborative, cross-functional team.

Qualifications

• Minimum 10+ years of experience in quality engineering or product development within the medical device industry.
• Experience with SaMD, AI/ML in medical devices is preferred.
• Familiarity with IEC 62304, ISO 13485, FDA/Notified Body processes.

Responsibilities

• Act as SME for global regulatory standards across software quality and design.
• Lead SDLC integration and validation frameworks for AI/ML, Cloud, and cybersecurity.
• Oversee design history file (DHF) and regulatory submissions with cross-functional teams.
• Provide mentorship and training to R&D, Product and Program teams.
• Direct V&V strategies and review test protocols and reports.
• Represent the QMS in internal and external audits (FDA, Notified Body, MDSAP).

Skills

Critical thinking

Attention to detail

Self-starter

Excellent communication

Leadership

Education

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

Master’s degree preferred

Job description

Heartflow seeks a Principal Device Quality Engineer to serve as the global SME for software quality and design excellence, bridging Agile development with medical device regulations. You will ensure safe, secure, compliant solutions, including SaMD and AI/ML-enabled tech, across the SDLC.

You will oversee end-to-end design control, advise on architecture, drive risk analysis, V&V, and DHF management, and lead regulatory submissions with a collaborative, cross-functional team.