Senior SaMD Quality Engineer – AI/ML & Regulatory Leader

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

Job summary

Heartflow in San Francisco is advancing AI-driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME for software quality and design excellence, aligning Agile development with medical device regulations across the SDLC.

Lead design control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR; mentor R&D, Product, and Program teams; drive compliance at speed in a regulated environment.

Qualifications

• Bachelor’s degree in software/CS/biomedical engineering required; Master’s preferred.
• 10+ years in quality engineering or product development within the medical device industry.
• Certifications (Preferred): CQE, CSQE, or Six Sigma Black Belt.
• Experience with core quality standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485) and regulatory submissions.

Responsibilities

• Provide strategic leadership as SME for global regulatory standards (IEC/ISO, FDA, MDSAP).
• Lead SDLC improvements for AI/ML, cloud, and cybersecurity within QMS.
• Oversee V&V activities; review test plans, protocols, and reports for safety and efficacy.
• Drive DHF management and support regulatory audits and inspections (FDA, Notified Bodies).
• Collaborate on regulatory submissions (FDA, PMDA, EU-MDR) and mentor R&D, Product, and Program teams.

Skills

Critical thinking

Self-starter

Communication and documentation

Time management

Education

Bachelor’s degree in Software Engineering / Computer Science / Biomedical Engineering

Master’s degree preferred

10+ years of quality engineering experience in medical devices

CQE / CSQE / Six Sigma Black Belt preferred

Job description

Heartflow in San Francisco is advancing AI-driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME for software quality and design excellence, aligning Agile development with medical device regulations across the SDLC.

Lead design control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR; mentor R&D, Product, and Program teams; drive compliance at speed in a regulated environment.