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 ResponsibilitiesLead verification and validation activities for ATEC AI/ML-enabled softwareDevelop AI validation plans, protocols and test strategiesDesign and curate validation data set, develop ground truthing methods and create ground truth dataDefine performance metrics, acceptance criteria, and statistical methods aligned with intended use.Conduct performance validation studies, including statistical analysis and data processing, and create study reportsAssess 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.