Senior AI Validation Engineer

ATEC Spine; Carlsbad (CA); On-site; USD 130,000 - 155,000; Full time

Job summary

A medical device company in California is seeking a Senior AI Validation Engineer to lead validation for AI/ML-enabled software utilized in medical devices. Ideal candidates will have substantial experience in AI model validation and data governance within regulatory frameworks. The role offers a competitive salary ranging from $130,000 to $155,000 annually, contingent on experience and qualifications. This position ensures that AI-enabled devices meet essential FDA and international standards.

Qualifications

• 6+ years in computer vision or machine learning / deep learning development.
• 2+ years in statistics or data science.
• Proficiency with AI/ML frameworks.

Responsibilities

• Lead verification and validation activities for AI/ML software.
• Develop AI validation plans and test strategies.
• Conduct performance validation studies and create reports.
• Assess model limitations, bias risks, and data representativeness.
• Ensure scientific rigor and transparency in validations.

Skills

Developing and validating AI models

Evaluating AI/ML model performance

Proficiency in Python

AI algorithm validation for FDA submission

Strong foundation in statistics

Managing large-scale datasets

Hands-on experience with AI/ML frameworks

Familiarity with FDA regulatory requirements

Education

Master's degree in a relevant field

PhD in a relevant field

Tools

PyTorch

Job description

Overview

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

• 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

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).

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.

Salary

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.