Senior Device Quality Engineer

The role

You will serve as a technical lead for software quality and design excellence. You will manage the end-to-end design control process within the Software Development Lifecycle for digital health solutions.

What you will do

• Apply global regulatory standards to daily development activities
• Implement validation frameworks for AI/ML, Cloud Infrastructure, and Cybersecurity
• Partner with engineering teams to ensure Agile sprints meet regulatory rigor
• Participate in software architecture reviews for safety and privacy-by-design
• Facilitate and document risk management activities
• Act as the lead for Software Verification and Validation
• Manage the Design History File from concept to commercialization
• Support the organization during internal and external audits
• Support Regulatory Affairs in authoring technical files for global submissions
• Provide technical coaching and quality training to R&D and Product teams

Required qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field
• 5–8 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

• ASQ Certified Quality Engineer (CQE)
• Certified Software Quality Engineer (CSQE)
• Green 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.