Design Quality Engineer at Senseye

Compensation

$100,000 – $125,000/yr

Setup: Hybrid
Location: Austin, Texas
Type: Full-time
Posted: Jun 22, 2026

Description

Senseye, a neurotechnology company focusing on mental health diagnostics, is seeking a Design Quality Engineer. This role involves partnering with various teams to develop robust, audit-ready quality processes for their software medical device (SaMD) platform. The ideal candidate will possess extensive experience in medical-device design quality, particularly in regulated software environments, along with hands-on involvement in SaMD lifecycle management.

Required Skills

design controls
software lifecycle documentation
risk management
regulated product development
ISO 13485
IEC 62304
FDA QMSR
Jira
GitHub
Confluence
eQMS systems

Additional Information

Required Previous Experiences: 4+ years in medical-device design quality, design assurance, or quality engineering for regulated software (design controls + software lifecycle)
Hands-on experience with design controls, risk management, software validation, traceability, and quality-system documentation.
Preferred Qualifications: 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.

About Senseye

Senseye

sensorThe Netherlands

Ssens is on top of the developments in the pharmaceutical and biomedical sciences and will stay committed to bring surface chemistry solutions to these communities.