Software Quality Engineer, SaMD / AI Medical Device
Company: Senseye
Location: Austin
Type: Full-time
Posted: 2026-06-10
About this role
About Us
Senseye is a NeuroTechnology Company in Austin, TX on the cusp of revolutionizing Mental Health. Over the past 6 years we have invested millions of dollars in R&D to build our platform allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform, that gives clinicians a safe and objective accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for hundreds of millions of sufferers. The Senseye platform has the potential to be the technology that drives this change.
Senseye is developing AI-enabled software medical devices to help make mental health assessment more objective, starting with PTSD. We are looking for a Software Quality Engineer who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready quality processes for SaMD development.
### Role Description
This is a hands-on role for someone who understands design controls, software lifecycle documentation, risk management, and regulated product development — and who wants to help shape the quality system rather than simply maintain one.
### Responsibilities
- Own and improve SaMD design-control deliverables, including user needs, design inputs/outputs, traceability, design reviews, verification/validation evidence, and DHF readiness.
- Partner with software, data science, clinical, and regulatory teams to apply IEC 62304, ISO 14971, ISO 13485:2016, FDA QMSR / 21 CFR Part 820, and applicable software quality prac...