Principal Device Quality Engineer

The role

You will serve as the global subject matter expert for software quality and design excellence. You will oversee compliance for the end to end design control process within the Software Development Lifecycle.

What you will do

• Act as the primary authority on global regulatory standards
• Lead the integration of modern technologies into the Quality Management System
• Partner with engineering teams to implement Compliance at Speed
• Advise on software architecture through safety, security-by-design, and privacy-by-design
• Support risk management activities including Hazard Analysis, Fault Tree Analysis, and FMEAs
• Act as technical lead for Software Verification and Validation
• Drive compliance from concept to commercialization and oversee the Design History File
• Represent the organization during internal and external audits and inspections
• Collaborate with Regulatory Affairs to author technical documentation
• Provide high-level technical guidance and training to R&D, Product and Program

Required 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
• Strong critical thinking skills
• Great attention to detail
• Ability to work as a self-starter in a fast-paced, adaptive environment
• Excellent communication, documentation, and time management skills

Nice to have

• Master’s degree
• ASQ Certified Quality Engineer (CQE)
• Certified Software Quality Engineer (CSQE)
• Six Sigma Black Belt

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The company is publicly traded (HTFL) and provides an AI-driven, non-invasive cardiac test.