Senseye, Inc. · 1 month ago
SaMD Quality Engineer/Sr. Engineer
Austin, TX
Full-time
Onsite
Mid, Senior Level
$97K/yr - $121K/yr
4+ years expSenseye, Inc. is a NeuroTechnology Company in Austin, TX focused on revolutionizing mental health through innovative diagnostics. The SaMD Quality Engineer/Sr. Engineer will oversee AI-enabled SaMD products, ensuring compliance with regulatory and quality standards throughout their lifecycle.
Health CareMental HealthNeuroscience
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
Qualification
Required
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
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
Company
Senseye, Inc.
Senseye is building a mental health visibility platform.
11-50 employees
H1B Sponsorship
Senseye, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
Funding
Current Stage
Early StageTotal Funding
$20.13MKey Investors
Topcon HealthcareMedTech Innovator
2025-09-09Corporate Round
2023-09-25Series Unknown· $12.18M
2023-06-06Non Equity Assistance
Leadership Team
David Zakariaie
CEO/Founder
Simon Woods
Co-Founder, Head of International Operations
Recent News
EIN Presswire
2025-12-05
2025-07-04
2025-02-05
Company data provided by crunchbase