Senior Quality Engineer

HeartFlow, Inc.; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

HeartFlow, Inc. seeks a Senior Quality Engineer to manage end-to-end design control for software quality and regulatory compliance in digital health solutions, ensuring safety and privacy standards are met.

Responsibilities include applying global regulatory standards, supporting risk management, audits, and maintaining the Design History File as SME for software processes to bridge development and compliance.

Qualifications

• Bachelor-level degree in a technical field (software/engineering).
• 5–8 years of experience in quality engineering or product development in medical devices.

Responsibilities

• Apply global regulatory standards to daily development activities and implement validation frameworks within the Quality Management System.
• Participate in software architecture reviews and risk management activities, ensuring safety and privacy principles are integrated.
• Manage the Design History File and support audits as SME for software processes.

Skills

Quality engineering

Software quality

Regulatory compliance

Education

Bachelor's degree in Software Engineering

Bachelor's degree in Computer Science

Job description

Bridging the gap between Agile development and medical device regulations, the full-time Senior Quality Engineer will manage the end-to-end design control process for software quality and compliance in digital health solutions, ensuring safety and security standards are met.

Key Responsibilities

• Apply global regulatory standards to daily development activities and implement validation frameworks within the Quality Management System
• Participate in software architecture reviews and facilitate comprehensive risk management activities, ensuring safety and privacy principles are integrated
• Manage the Design History File and support the organization during internal and external audits as a subject matter expert for software processes

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
• Certifications preferred: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt