Senior Design Quality Engineer

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