Senior SaMD Quality Engineer – AI/ML & Regulatory

Heartflowinc; San Francisco (CA); Hybrid; USD 165,000 - 205,000; Full time

Benefits offered by this job

Bonus

Equity

Job summary

Heartflowinc in San Francisco is seeking a Staff Device Quality Engineer to oversee software quality across multiple product lines. You will lead the execution of regulatory standards and ensure compliance in fast-paced Agile development environments.

The ideal candidate has significant experience in quality engineering within the medical device field, with strong leadership and communication skills. This role also offers a competitive salary and benefits.

Qualifications

• 10+ years of experience in quality engineering in the medical device industry.
• At least 3 years in a senior lead quality engineering role for SaMD or AI/ML products.
• Certifications such as ASQ Certified Quality Engineer or Certified Software Quality Engineer preferred.

Responsibilities

• Lead the application and interpretation of global regulatory standards.
• Architect and own validation frameworks for AI/ML and Cloud Infrastructure.
• Define and own the organization-wide Software Verification and Validation strategy.

Skills

Critical thinking

Attention to detail

Self-starter

Communication skills

Influencing skills

Education

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

Master’s degree preferred

Job description

Heartflowinc in San Francisco is seeking a Staff Device Quality Engineer to oversee software quality across multiple product lines. You will lead the execution of regulatory standards and ensure compliance in fast-paced Agile development environments.

The ideal candidate has significant experience in quality engineering within the medical device field, with strong leadership and communication skills. This role also offers a competitive salary and benefits.