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.
Requirements
- Substantial experience developing and validating AI models for medical devices or healthcare applications.
- Demonstrated experience evaluating AI/ML model performance using quantitative and statistical methods.
- Proficiency in Python or similar scripting/statistical languages.
- Experienced in AI algorithm validation for FDA submission
- Strong foundation in statistics, experimental design, and descriptive data analysis
- Experience managing large-scale datasets using commercial or enterprise data tools
- Hands-on experience with AI/ML frameworks such as PyTorch
- Familiarity with FDA regulatory requirements, regulated product development and quality systems (e.g., design controls, risk management, validation documentation).
- Familiar with LLM based generative AI technologies
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance