Senior AI Validation Engineer

Alphatec Spine•Carlsbad, CA

1d•$130,000 - $155,000

About The Position

The Senior AI Validation Engineer is responsible for leading validation activities for AI/ML-enabled software and software-driven medical device systems across new product development and sustaining engineering. Under minimal supervision, this role provides senior-level technical expertise in AI model validation, data governance, risk management, and regulatory compliance, ensuring AI-enabled medical devices meet FDA and international regulatory requirements throughout the total product lifecycle. This role works cross-functionally with Quality Engineering, R&D, Data Science, Clinical, Product Development, and Regulatory Affairs to ensure scientific rigor, transparency, bias mitigation, and traceability in AI/ML system validation.

Requirements

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).

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.