Senior SaMD Quality Engineer - AI/ML & Cloud, Hybrid

Regulatory Jobs; San Francisco (CA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Hybrid work

Bonus potential

Job summary

Heartflow is seeking a Senior Device Quality Engineer to lead end-to-end design control within the Software Development Lifecycle. You will ensure safety-by-design and privacy-by-design, bridging Agile development with medical device regulations.

You will manage the DHF, participate in design reviews, perform risk analyses, and drive V&V activities to ensure compliant, high-quality releases across global submissions. This role requires 5–8 years in medical device quality engineering.

Qualifications

• Experience applying IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.
• Experience leading software validation for AI/ML, cloud SaaS, and cybersecurity in QMS.
• Proven ability to operate in a fast-paced, regulated medical device environment.

Responsibilities

• Lead end-to-end design control within Heartflow’s SDLC.
• Own design history file (DHF) from concept to commercialization.
• Support audits (FDA, Notified Bodies, MDSAP) as software SME.
• Coach R&D and Product teams on regulatory compliance.

Skills

Regulatory compliance

Quality engineering

SDLC knowledge

Regulatory audits

Communication skills

Education

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

Job description

Heartflow is seeking a Senior Device Quality Engineer to lead end-to-end design control within the Software Development Lifecycle. You will ensure safety-by-design and privacy-by-design, bridging Agile development with medical device regulations.

You will manage the DHF, participate in design reviews, perform risk analyses, and drive V&V activities to ensure compliant, high-quality releases across global submissions. This role requires 5–8 years in medical device quality engineering.