Senior Design Quality Engineer

Job Summary

To support a growing healthcare technology startup, the full-time Senior Design Quality Engineer will manage product quality for an FDA-cleared AI-driven clinical platform, overseeing design controls, complaint investigations, and quality management systems in a remote environment.

Key responsibilities

• Partner with engineering and data science teams throughout the software lifecycle to ensure compliance with design controls and risk management standards
• Assess software and model changes for regulatory impact and drive necessary changes through the quality management system
• Support complaint handling processes, including investigation and reporting, while maintaining quality procedures and compliance records

Required qualifications

• A BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical field, or equivalent practical experience
• 5+ years of experience in software quality or regulatory work for medical devices, including design controls and risk management
• Experience with complaint handling and adverse event reporting under relevant FDA regulations
• Proven track record of maintaining and improving quality management system procedures in a regulated environment
• Ability to read code and logs to investigate software issues independently