SaMD Quality Engineer/Sr. Engineer jobs in United States
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Senseye, Inc. · 1 month ago

SaMD Quality Engineer/Sr. Engineer

positionAustin, Texas, United States
timeFull-time
remoteOnsite
seniorityMid, Senior Level

Senseye, Inc. is a NeuroTechnology Company in Austin, TX focused on revolutionizing mental health through innovative diagnostics. They are seeking a highly skilled Software as Medical Device (SaMD) Quality Engineer to oversee AI-enabled SaMD products throughout their lifecycle, ensuring compliance with regulatory and quality standards.

Health CareMental HealthNeuroscience
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Growth Opportunities
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H1B Sponsor Likelynote

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

SaMD design experienceISO 13485 complianceRisk management ISO 14971Machine Learning PracticesCybersecurity requirementsUsability EngineeringSupplier qualification strategiesAgile software practicesRoot cause analysisQuality metrics reportingInformation security compliance

Required

Substantial experience in SaMD design, development, and medical device quality systems
Experience with ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971 and other applicable standards
Experience in developing and reviewing design control documentations and facilitating design reviews
Knowledge of Good Machine Learning Practices (GMLP) and latest FDA guidances
Experience in risk management activities per ISO 14971, including creation and maintenance of risk analyses
Collaboration experience with development teams on cybersecurity requirements, threat modeling, vulnerability assessments, and post-market monitoring
Experience in Usability and Human Factor Engineering related activities for SaMD
Experience in defining and implementing non-product software validation strategies in alignment with FDA's CSA guidance, 21 CFR Part 11 and GAMP 5 principles
Experience in defining and implementing supplier qualification strategies
Experience in developing and continuous improvement of SaMD QMS processes
Experience in investigating and resolving product quality issues, nonconformances, and CAPAs using root cause analysis techniques
Experience in leading or supporting internal and external audits (e.g., FDA, Notified Bodies, ISO registrars)
Experience in monitoring post-market product performance and contributing to complaint handling and field actions
Experience in driving quality metrics reporting and trend analysis to support management reviews and continuous improvement initiatives
Experience in performing agile software development/quality practices
Knowledge of establishing information security against HIPAA, GDPR requirements

Company

Senseye, Inc.

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Senseye is building a mental health visibility platform.
dateFounded in 2015
location
Austin, Texas, USA
people-size11-50 employees
web-link
https://senseye.co

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 Stage
Total Funding
$20.13M
Key Investors
Topcon HealthcareMedTech Innovator
2025-09-09Corporate Round
2023-09-25Series Unknown· $12.18M
2023-06-06Non Equity Assistance

Leadership Team

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David Zakariaie
CEO/Founder
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Simon Woods
Co-Founder, Head of International Operations
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