SaMD Quality Engineer/Sr. Engineer at Senseye

Austin, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

121000.0

Posted On

15 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SaMD, Quality Engineering, Regulatory Compliance, Risk Management, Software Validation, Design Control, Cybersecurity, Usability Engineering, Human Factor Engineering, Good Machine Learning Practices, ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 820, Agile Software Development, Problem Solving

Industry

Research Services

Description

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. Role Description We are seeking a highly skilled Software as Medical Device (SaMD) Quality Engineer with substantial experience in SaMD design, development, and medical device quality systems. This pivotal role involves overseeing our AI-enabled SaMD products across the entire lifecycle—from initial development through post-market surveillance, ensuring adherence to all regulatory, quality, and customer requirements. The role title (Engineer or Sr. Engineer) will be commensurate with the candidate's experience level. Responsibilities Partner with Engineering, R&D, Regulatory, and Clinical teams to ensure compliance with ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971 and other applicable standards. Support design and development activities by developing and reviewing design control documentations and facilitating design reviews to ensure compliance with Senseye QMS and regulatory requirements. Ensure AI/ML Models are developed in accordance with Good Machine Learning Practices (GMLP) and latest FDA guidances. Perform risk management activities per ISO 14971, including creation and maintenance of risk analyses. Collaborate with development teams on cybersecurity requirements, threat modeling, vulnerability assessments, and post-market monitoring in accordance with FDA guidances, and other international standards to ensure product security. Perform Usability and Human Factor Engineering related activities for SaMD Define and implement and non-product software validation strategies in alignment with FDA’s CSA guidance, 21 CFR Part 11 and GAMP 5 principles. Define and implement supplier qualification strategies. Contribute to the development and continuous improvement of the SaMD QMS processes Investigate and resolve product quality issues, nonconformances, and CAPAs using root cause analysis techniques. Lead or support internal and external audits (e.g., FDA, Notified Bodies, ISO registrars). Monitor post-market product performance and contribute to complaint handling and field actions when needed. Drive quality metrics reporting and trend analysis to support management reviews and continuous improvement initiatives. Perform agile software development/quality practices Establish information security against HIPAA, GDPR requirements Ability to think outside the box and come up with new ways to solve challenging problems. Bachelor’s degree in Science or Engineering, or related technical discipline. 4+ years of experience in medical device quality engineering with 2+years in the SaMD/SiMD environment (SaMD/SiMD experience is a must!) Strong understanding of quality systems and regulatory frameworks, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820/11. Experience with design control, risk management, and software validation. Familiarity with Github, Jira, Confluence, and modern eQMS tools. Excellent communication, collaboration, and problem-solving skills. 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 $97,000 - $121,000 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.

Responsibilities

Oversee AI-enabled SaMD products throughout their lifecycle, ensuring compliance with regulatory and quality requirements. Collaborate with various teams to support design and development activities and monitor post-market product performance.