Software as Medical Device (SaMD) Quality Engineer

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., Agile Programming Methodologies, Artificial Intelligence (AI), Atlassian JIRA, Cellular Telephone, Clinical Trial, Code of Federal Regulations, Communication Skills, Computer Security, Continuous Improvement, Customer Support/Service, Dental Insurance, Disease, Document Management, External Audit, FDA (Food and Drug Administration), GitHub, HIPAA (Health Insurance Portability and Accountability Act), Health Plan, Healthcare, Healthcare Quality, Human Factors, ISO (International Organization for Standardization), Information/Data Security (InfoSec), Internal Audit, International Electro-Technical Commission (IEC), Internet Security, Life Insurance, Machine Learning, Maintain Compliance, Market Tracking, Medical Equipment, Post Traumatic Stress Disorder (PTSD), Problem Solving Skills, Process Improvement, Product Shipments, Product Strategy, Product Testing, Psychiatry and Mental Health, Quality Engineering, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, Software Development, Software Validation, Surveillance, Threat Modeling, Trend Analysis, Usability Engineering, Use Cases, Vendor/Supplier Planning, Vision Plan

• 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 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.