Design Quality Engineer, Software Medical Device

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 Design Quality Engineer for our software medical device (SaMD) 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. This is an intersection role: it requires both medical-device design-controls/quality experience and hands-on software / SaMD lifecycle experience ? not one or the other. Requirements This role requires both of the following, not either/or:

• 4+ years in medical-device design quality, design assurance, or quality engineering for regulated software (design controls + software lifecycle).
• 2+ years hands-on with SaMD, SiMD, or medical-device software (including digital health / diagnostics software).
• Hands-on experience with design controls, risk management, software validation, traceability, and quality-system documentation.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QMSR / 21 CFR Part 820, and 21 CFR Part 11.
• Comfort working directly with software teams using tools such as Jira, GitHub, Confluence, and eQMS systems.

• 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 practices.
• Support AI/ML model lifecycle quality practices, including documentation, risk controls, change control, validation evidence, and total-product-lifecycle thinking.
• Help define pragmatic QMS processes for a fast-moving regulated startup, including software development, non-product software validation / CSA, supplier controls, CAPA, and audit readiness.
• Contribute to cybersecurity, usability/HFE, post-market, complaint, and quality-metrics activities in partnership with subject-matter experts

• AI/ML-enabled medical-device experience.
• Familiarity with IMDRF GMLP principles.
• Cybersecurity documentation experience for medical devices.
• Usability / human factors engineering experience.
• FDA submission, audit, notified-body, CAPA, or post-market experience.
• Experience in a startup or early-stage regulated product environment.

Why this role is compelling You will help shape the quality foundation for an AI-enabled SaMD product, not just maintain inherited procedures.

• You will work cross-functionally with engineering, clinical, regulatory, product, and data science teams.
• You will have direct impact on design controls, software lifecycle quality, risk management, and audit readiness.
• You will join at a stage where quality decisions still materially shape how the product and QMS scale.

• The freedom and trust to define your role as we design, build, and ship our products
• Competitive salary and stock option plan
• Flexible paid time off (vacation, sick leave, and public holidays)
• Flexible schedules
• Company health care plan
• Medical, dental, and vision insurance
• Short and long term disability insurance
• Life insurance policy
• 401k
• Commuter benefits for parking, public transit, carshares, etc.
• Mothers' room
• Fully stocked kitchen
• Opportunities for continuing education

The compensation for this role is $100,000 - $125,000 annually.

Senseye is dedicated to building a community of employees that are diverse, passionate, and engaged. We are committed to equal opportunity regardless of race, color, ancestry, religion, gender, gender identity, parental or pregnancy status, national origin, sexual orientation, age, marital status, disability, or veteran status. When we're safe, healthy, and balanced we can accomplish phenomenal things together.