Lead AI Validation Engineer for Medical Devices (FDA-ready)

ATEC Spine; Carlsbad (CA); On-site; USD 130,000 - 155,000; Full time

Job summary

A medical device company in California is seeking a Senior AI Validation Engineer to lead validation for AI/ML-enabled software utilized in medical devices. Ideal candidates will have substantial experience in AI model validation and data governance within regulatory frameworks. The role offers a competitive salary ranging from $130,000 to $155,000 annually, contingent on experience and qualifications. This position ensures that AI-enabled devices meet essential FDA and international standards.

Qualifications

• 6+ years in computer vision or machine learning / deep learning development.
• 2+ years in statistics or data science.
• Proficiency with AI/ML frameworks.

Responsibilities

• Lead verification and validation activities for AI/ML software.
• Develop AI validation plans and test strategies.
• Conduct performance validation studies and create reports.
• Assess model limitations, bias risks, and data representativeness.
• Ensure scientific rigor and transparency in validations.

Skills

Developing and validating AI models

Evaluating AI/ML model performance

Proficiency in Python

AI algorithm validation for FDA submission

Strong foundation in statistics

Managing large-scale datasets

Hands-on experience with AI/ML frameworks

Familiarity with FDA regulatory requirements

Education

Master's degree in a relevant field

PhD in a relevant field

Tools

PyTorch

Job description

A medical device company in California is seeking a Senior AI Validation Engineer to lead validation for AI/ML-enabled software utilized in medical devices. Ideal candidates will have substantial experience in AI model validation and data governance within regulatory frameworks. The role offers a competitive salary ranging from $130,000 to $155,000 annually, contingent on experience and qualifications. This position ensures that AI-enabled devices meet essential FDA and international standards.