Test Method Validation Engineer

Test Method Validation EngineerLocation: Delaware, United StatesLong-Term Project Key Responsibilities:Lead and oversee Test Method Validation (TMV) execution activities.Review and support development of TMV protocols, test methods, and acceptance criteria.Mentor and coach validation engineers on TMV best practices.Support software and hardware validation activities.Ensure accurate execution and documentation of validation test cases.Identify and resolve technical issues during validation testing.Ensure compliance with FDA regulations, design controls, and quality requirements.Required Qualifications:Bachelor's degree in engineering or a related field.10+ years of experience in Test Method Validation (TMV).Hands-on experience executing TMV test cases.Experience as a TMV Lead, SME, Supervisor, or Validation Lead.Strong background in software and hardware validation within the medical device industry.Preferred Qualifications:Experience with mammography, MRI, or other medical imaging systems.Knowledge of FDA regulations, design controls, and verification & validation (V&V).