Job Description

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, d...

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