SaMD Quality Engineer/Sr. Engineer

Senseye • Austin, TX

8d • $97,000 - $121,000

About The Position

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.

Requirements

• 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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees