Senior AI Validation Engineer

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.

Essential Duties and 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.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

Education and Experience

• 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.

Equal Employment Opportunity & Other Disclosures

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

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).

At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $130,000 to $155,000 Full-Time Annual Salary

Please Note: The employer will not sponsor applicants for work visas for this position.