About the job
As a Senior AI Validation Engineer at ATEC Spine, you will spearhead the validation processes for AI/ML-integrated software and software-driven medical device systems throughout the phases of new product development and ongoing engineering efforts. This pivotal position operates with a high degree of autonomy, providing advanced technical insights into AI model validation, data governance, risk management, and adherence to regulatory standards, thereby ensuring that AI-enabled medical devices comply with FDA and international regulations over the entire product lifecycle.
You will collaborate extensively with teams across Quality Engineering, R&D, Data Science, Clinical, Product Development, and Regulatory Affairs to uphold scientific integrity, transparency, bias reduction, and traceability in AI/ML system validation.
Key Responsibilities:
- Lead the verification and validation initiatives for ATEC’s AI/ML-enabled software solutions.
- Formulate AI validation strategies, protocols, and testing methodologies.
- Design and manage validation datasets, develop ground truthing techniques, and generate ground truth data.
- Establish performance metrics, acceptance criteria, and statistical methodologies in alignment with intended applications.
- Execute performance validation studies, including statistical evaluations and data processing, and compile comprehensive study reports.
- Evaluate and document model limitations, potential biases, and the representativeness of data.
- Oversee data management associated with validation efforts, ensuring independence of datasets and proper training/validation/test separations.
- Assist in risk management activities as per ISO 14971, focusing on AI-specific hazards and potential failure modes.
- Prepare and review Computer Software Validation (CSV) documentation in accordance with FDA guidelines.
- Contribute AI/ML validation documentation for FDA submissions (510(k), De Novo, PMA).
- Work collaboratively to ensure regulatory preparedness and provide technical support to various departments.
- Perform other related tasks as assigned.