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Product Quality Engineer - SaMD

$97,000/year

Senseye

Austin, TX, USA

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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 Product Quality Engineer with strong experience in software and medical device quality systems to join our team. This individual will play a critical role in ensuring that our SaMD products meet regulatory, quality, and customer requirements throughout the product lifecycle—from development through post-market surveillance. Responsibilities Partner with Engineering, R&D, Regulatory, and Clinical teams to ensure compliance with ISO 13485, 21 CFR Part 820, IEC 62304, and other applicable standards. Support design and development activities by developing and reviewing documentation, ensuring design control compliance, and participating in design reviews. 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, ISO/IEC 27001, and other international standards to ensure product security. Define and implement non-product software validation strategies in alignment with FDA’s CSA guidance, 21 CFR Part 11 and GAMP 5 principles. Contribute to the development and continuous improvement of the QMS, with a focus on software-specific quality 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). Participate in supplier qualification and software supplier evaluation processes. 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. Position requires access to Covered Defense Information for which the US Government requires US Citizenship You'll also need to pass an FBI background check Senseye maintains a drug free workplace and conducts pre-employment substance abuse testing. Senseye may also conduct substance abuse testing during employment, in accordance with its policies and customer requirements. Employment is subject to successfully completing and passing such tests. Requirements Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline. 4+ years of experience in medical device quality engineering with 2+years in the SaMD environment (SaMD 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 Jira, Confluence, and modern QMS or eQMS tools. Excellent communication, collaboration, and problem-solving skills. Extra Points: Perform agile software development/quality practices Perform Usability and Human Factor Engineering activities for medical devices Establish information security against HIPAA, GDPR requirements The compensation for this role is $97,000 - $121,000 annually. Benefits 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 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.

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Austin, TX, USA
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