Senior AI Data and Evaluation Engineer

What You Will Do

Senior AI Data and Validation Engineer responsible for both dry‑ and wet‑lab experiments to acquire datasets, develop labeling guidelines, and prepare data for AI model development. The engineer will develop scientific evaluation methods for AI/ML models used in medical devices, ensuring FDA guideline compliance throughout the product lifecycle. The role focuses on comprehensive data management practices, data integrity, bias mitigation, and safety, effectiveness, and quality demonstration for AI‑enabled medical devices.

• Collect, synthesize, generate, and stress‑test datasets for AI development.
• Execute wet‑lab experiments with biological samples following good laboratory practice.
• Create detailed validation plans, protocols, and reports for AI‑enabled medical device software functions, covering performance validation and model evaluation.
• Manage data used in development and validation of AI models, ensuring quality, diversity, independence, representativeness, bias assessment, and separation of training/test datasets.
• Conduct comprehensive risk assessment for AI models, addressing potential biases, limitations, and cybersecurity vulnerabilities.
• Perform rigorous performance validation studies, analyzing performance across different subgroups of the intended user population.
• Analyze transparency and bias throughout the device lifecycle, from design to post‑market surveillance, ensuring equitable benefits across demographic groups and incorporating transparency into device design.
• Stay current with the latest FDA guidelines, regulations, and industry best practices related to AI model validation in medical devices.

• Bachelor’s Degree in Computer Science, Machine Learning, Electrical Engineering, Mathematics, Statistics, Bioengineering, or related field with 2+ years of work experience.
• OR Master’s Degree in the above fields.

• 2+ years of experience in medical device R&D, preferably AI‑enabled devices.
• Fluent in commercial data analysis tools or similar scripting and statistical languages for data analysis;
  Python preferred.
• Experience developing, evaluating, and validating AI models within medical device or healthcare industry, covering data acquisition, preprocessing, labeling, training, tuning, bias detection, risk assessment, and QMS documentation.
• Experience with statistical analysis (confidence intervals, power analysis, statistical tests) to support AI model validation.
• Entry‑level knowledge of AI/ML frameworks (PyTorch, OpenCV, Tensor Flow, scikit‑learn) for model training, development, testing, and validation.
• Experience with commercial Data Operation tools.
• General knowledge of the healthcare market and competitors.

Salary: $116k – $193k plus bonus eligibility and benefits. Compensation based on skills, experience, and other factors.

Health benefits:

medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, wellbeing program, and tobacco cessation program.

Financial benefits:

Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance.