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Senior AI Validation Engineer

ATEC SpineCarlsbad, California, United States
On-site Full-time $130K/yr - $155K/yr

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Experience Level

Senior

Qualifications

The following qualifications are essential for success in this role:Extensive experience in developing and validating AI models specifically for medical devices or healthcare applications. Proven track record in assessing AI/ML model performance through quantitative and statistical methodologies. Proficiency in Python or similar programming/statistical languages. Experience in AI algorithm validation for FDA submissions. A solid grounding in statistics, experimental design, and descriptive data analysis. Skilled in managing large datasets utilizing commercial or enterprise data tools. Hands-on experience with AI/ML frameworks such as PyTorch. Familiarity with FDA regulatory requirements and quality systems relevant to regulated product development.

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.

About ATEC Spine

ATEC Spine is a leading innovator in spinal surgery solutions, committed to advancing the field through state-of-the-art medical devices and technologies. Our collaborative environment encourages creativity and excellence, allowing our employees to contribute to impactful advancements in healthcare.

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