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.