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Test Method Validation Engineer
Job in
Elsmere, New Castle County, Delaware, USA
Listed on 2026-07-17
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-07-17
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- 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.
- 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.
- Experience with mammography, MRI, or other medical imaging systems
. - Knowledge of FDA regulations, design controls, and verification & validation (V&V).
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