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ATEC Spine · 1 week ago

Senior AI Validation Engineer

Carlsbad, CA

Full-time

Onsite

Senior Level

$130K/yr - $155K/yr

6+ years exp

ATEC Spine is a company focused on developing AI/ML-enabled software and software-driven medical device systems. The Senior AI Validation Engineer will lead validation activities, ensuring compliance with FDA and international regulations while collaborating with various departments to maintain scientific rigor and transparency in AI system validation.

Health CareMedical DeviceProduct Design

No H1B

Responsibilities

Lead verification and validation activities for ATEC AI/ML-enabled software

Develop AI validation plans, protocols and test strategies

Design and curate validation data set, develop ground truthing methods and create ground truth data

Define performance metrics, acceptance criteria, and statistical methods aligned with intended use

Conduct performance validation studies, including statistical analysis and data processing, and create study reports

Assess and document model limitations, bias risks, and data representativeness

Oversee validation-related data management, including dataset independence and training/validation/test separation

Support risk management activities per ISO 14971, including AI-specific hazards and failure modes

Prepare and review Computer Software Validation (CSV) documentation per FDA guidance

Contribute AI/ML validation content to FDA submissions (510(k), De Novo, PMA)

Collaborate cross-functionally to ensure regulatory readiness and provide technical guidance to other departments

Other duties as assigned

Qualification

AI model validationFDA regulatory complianceStatistical analysisPython proficiencyAI algorithm validationLarge-scale dataset managementAI/ML frameworksRisk managementDescriptive data analysisCross-functional collaboration

Required

Substantial experience developing and validating AI models for medical devices or healthcare applications

Demonstrated experience evaluating AI/ML model performance using quantitative and statistical methods

Proficiency in Python or similar scripting/statistical languages

Experienced in AI algorithm validation for FDA submission

Strong foundation in statistics, experimental design, and descriptive data analysis

Experience managing large-scale datasets using commercial or enterprise data tools

Hands-on experience with AI/ML frameworks such as PyTorch

Familiarity with FDA regulatory requirements, regulated product development and quality systems (e.g., design controls, risk management, validation documentation)

Familiar with LLM based generative AI technologies

6+ years of experience in computer vision and/or machine learning / deep learning development (4+ years with a master's degree and 2+ years with a PhD)

2+ years of experience in statistics, descriptive data analysis, or data science

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable)