Principal Risk Quality Engineer

Heartflowinc

California, United States
Base: $185,000 - $240,000; bonus/equity: bonus, + ...
On-site
Iso 14971 risk management
Ai/ml risk evaluation
Cybersecurity risk assessment
Heartflow is seeking a Principal Risk Quality Engineer to lead their product Risk Management process for innovative digital health solutions. The ideal candidate will have extensive experience in Risk Management within the medical device industry, with a focus on safety and compliance

Job Summary

  • Own the product Risk Management process and serve as the global subject expert for Product Safety and Risk Management.
  • Lead the end-to-end Risk Management process, ensuring clinical risks are identified, mitigated, and verified before reaching a patient.
  • Partner with Clinical Affairs to author Benefit-Risk Assessments for global regulatory submissions and defend technical integrity during inspections.

Matching Summary

Match Score: 85

Heartflow is seeking a Principal Risk Quality Engineer to lead their product Risk Management process for innovative digital health solutions. The ideal candidate will have extensive experience in Risk Management within the medical device industry, with a focus on safety and compliance.

Salary

Base: $185,000 - $240,000; Bonus/Equity: bonus, and equity; Benefits: Not specified

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • AI/ML Risk Evaluation
  • Cybersecurity Risk Assessment
  • Benefit-Risk Analysis
  • Post-Market Risk Surveillance

Nice-to-have

  • Safety-by-Design workshops
  • Clinical harm translation
  • Global subject matter expert

Key Requirements

  • Master's degree strongly preferred
  • 10+ years of experience in Risk Management or Quality Engineering
  • Bachelor’s degree in Biomedical Engineering, Systems Engineering, or related technical field
  • ASQ Certified Risk Management Professional (Preferred)
  • Six Sigma Black Belt (Preferred)
  • ISO 14971 Lead Auditor (Preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter