Design Quality Engineer, Software Medical Device

Senseye•Austin, TX

3h•$100,000 - $125,000•Onsite

About The Position

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. 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

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.

Nice To Haves

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.

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 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