Principal Risk Quality Engineer

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The Principal Risk Quality Engineer will own the product Risk Management process and serve as the global subject expert for Product Safety and Risk Management.

Requirements

• Strong critical thinking skills
• Mastery of Risk Estimation, Evaluation, and Control methodologies
• Ability to translate technical software bugs into potential clinical patient harms
• Strategic Leadership
• Risk Governance
• Safety Architecture
• Cybersecurity
• Risk Culture
• Design Quality & Risk Management
• Advanced Risk Modeling
• Benefit-Risk Analysis
• V&V Alignment
• Execution & Compliance
• Risk Management File (RMF) Ownership
• Post-Market Risk Surveillance
• Health Hazard Evaluations (HHEs)
• Audit Representation
• Cross-Functional Collaboration
• Clinical Collaboration
• Regulatory Submissions

Benefits

• Estimated base salary of $185,000 - $240,000
• Bonus
• Equity
• Health, Dental, Vision, and Life Insurance
• Retirement Savings Plan
• Flexible PTO Policy
• Mental Health Days
• Employee Assistance Program
• 401(k) Matching
• Stock Options