Principal Quality Engineer, SaMD & AI/ML (Hybrid)

Regulatory Jobs; San Francisco (CA); Hybrid; USD 188,000 - 240,000; Full time

Job summary

Heartflow seeks a Principal Device Quality Engineer to be the global SME for software quality and design excellence, bridging Agile development with medical device regulations. You will oversee end-to-end design control within Heartflow’s SDLC, guiding architecture, security-by-design, and regulatory submissions.

You will lead risk analyses (Hazard, FTA, FMEAs) and V&V, manage the DHF, and support post-market vigilance.

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field.
• 10+ 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 Six Sigma Black Belt.

Responsibilities

• Act as global SME for software quality, design excellence, and regulatory standards (IEC 62304, IEC 82304, ISO 14971, ISO 13485, AAMI TIR45).
• Lead the integration of modern SDLC practices to validate AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity in QMS.
• Oversee design control across the SDLC and guide architecture from safety and privacy perspectives.
• Lead risk analyses including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs for software.
• Direct V&V activities; approve test strategies, protocols, and reports for robust product performance.
• Drive Design History File (DHF) management and smooth design transfer.
• Represent software QMS in FDA, Notified Body, MDSAP audits and inspections.
• Collaborate with Regulatory Affairs on global submissions (FDA, PMDA, EU-MDR) and mentor R&D teams.

Skills

Critical thinking

Attention to detail

Self-starter

Communication skills

Documentation skills

Time management

Education

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

Master’s degree preferred

Job description

Heartflow seeks a Principal Device Quality Engineer to be the global SME for software quality and design excellence, bridging Agile development with medical device regulations. You will oversee end-to-end design control within Heartflow’s SDLC, guiding architecture, security-by-design, and regulatory submissions.

You will lead risk analyses (Hazard, FTA, FMEAs) and V&V, manage the DHF, and support post-market vigilance.