{"schemaVersion":"jobsearcher.job.v1","id":"c38928e66f40d52e4b5cb149","url":"https://jobsearcher.com/jobs/c38928e66f40d52e4b5cb149","canonicalUrl":"https://jobsearcher.com/jobs/c38928e66f40d52e4b5cb149","title":"Test Method Validation Engineer","description":"Role: TMV Engineer Location: Newark, DEDuration: 6–9 Months Initially Position OverviewThe contractor will be responsible for Test Method Validation (TMV) and Design Verification/Validation (DV/DT&V) activities, including hands-on test execution, test method development, measurement system analysis, statistical evaluation, and technical documentation.This position will also serve as a technical SME/lead for TMV activities, providing guidance and mentoring to other TMV engineers and specialists. Key ResponsibilitiesDevelop and validate test methods for complex electromechanical medical device systems to verify clinical, system, and product performance requirements.Translate design and clinical requirements into repeatable, reproducible, and validation-ready test methods.Develop TMV protocols, test fixtures, measurement techniques, acceptance criteria, and validation strategies.Lead and execute Test Method Validation (TMV) studies supporting Design Verification and Design Validation activities.Perform Gauge R&R, Repeatability & Reproducibility (R&R), Measurement System Analysis (MSA), and related statistical assessments.Identify measurement and control requirements for test methods and determine appropriate measurement equipment.Assess equipment suitability and measurement capability for specific test methods.Identify potential sources of measurement variability and determine whether MSA or additional validation is required.Perform hands-on laboratory testing, data collection, troubleshooting, and statistical analysis.Develop TMV protocols and reports demonstrating accuracy, precision, repeatability, reproducibility, and robustness.Execute test cases required to support product commercialization.Ensure TMV and verification/validation documentation complies with FDA 21 CFR Part 820, ISO 13485, and applicable medical device quality requirements.Troubleshoot test method issues and work with engineering, quality, and product development teams to resolve technical problems.Serve as the TMV Subject Matter Expert (SME) and technical point of contact for other TMV engineers.Mentor and provide technical guidance to junior engineers and TMV specialists. Required QualificationsStrong experience in Test Method Validation (TMV) within the medical device industry.Experience supporting Design Verification and Validation (DV/V) activities for medical devices.Hands-on experience developing and validating test methods for electromechanical or complex medical device systems.Strong knowledge of Gauge R&R, MSA, Repeatability & Reproducibility, and statistical analysis.Experience developing TMV protocols, reports, acceptance criteria, and test procedures.Experience with laboratory testing, measurement equipment, data collection, and troubleshooting.Strong understanding of measurement variability, measurement system capability, accuracy, precision, repeatability, reproducibility, and robustness.Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.Strong technical documentation and technical writing skills.Ability to work as a TMV SME/Lead and mentor junior engineers.Must be comfortable working onsite in Newark, Delaware.","company":"United Pharma Technologies","rawCompany":"united pharma technologies","city":"Newark","state":"DE","isRemote":false,"isActive":false,"createdAt":"2026-08-12T11:06:43.862Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1253.00","title":"Software Quality Assurance Analysts and Testers","slug":"software-quality-assurance-analysts-and-testers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541380","title":"Testing Laboratories and Services","slug":"testing-laboratories-and-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Test Method Validation Engineer","description":"Role: TMV Engineer Location: Newark, DEDuration: 6–9 Months Initially Position OverviewThe contractor will be responsible for Test Method Validation (TMV) and Design Verification/Validation (DV/DT&V) activities, including hands-on test execution, test method development, measurement system analysis, statistical evaluation, and technical documentation.This position will also serve as a technical SME/lead for TMV activities, providing guidance and mentoring to other TMV engineers and specialists. Key ResponsibilitiesDevelop and validate test methods for complex electromechanical medical device systems to verify clinical, system, and product performance requirements.Translate design and clinical requirements into repeatable, reproducible, and validation-ready test methods.Develop TMV protocols, test fixtures, measurement techniques, acceptance criteria, and validation strategies.Lead and execute Test Method Validation (TMV) studies supporting Design Verification and Design Validation activities.Perform Gauge R&R, Repeatability & Reproducibility (R&R), Measurement System Analysis (MSA), and related statistical assessments.Identify measurement and control requirements for test methods and determine appropriate measurement equipment.Assess equipment suitability and measurement capability for specific test methods.Identify potential sources of measurement variability and determine whether MSA or additional validation is required.Perform hands-on laboratory testing, data collection, troubleshooting, and statistical analysis.Develop TMV protocols and reports demonstrating accuracy, precision, repeatability, reproducibility, and robustness.Execute test cases required to support product commercialization.Ensure TMV and verification/validation documentation complies with FDA 21 CFR Part 820, ISO 13485, and applicable medical device quality requirements.Troubleshoot test method issues and work with engineering, quality, and product development teams to resolve technical problems.Serve as the TMV Subject Matter Expert (SME) and technical point of contact for other TMV engineers.Mentor and provide technical guidance to junior engineers and TMV specialists. Required QualificationsStrong experience in Test Method Validation (TMV) within the medical device industry.Experience supporting Design Verification and Validation (DV/V) activities for medical devices.Hands-on experience developing and validating test methods for electromechanical or complex medical device systems.Strong knowledge of Gauge R&R, MSA, Repeatability & Reproducibility, and statistical analysis.Experience developing TMV protocols, reports, acceptance criteria, and test procedures.Experience with laboratory testing, measurement equipment, data collection, and troubleshooting.Strong understanding of measurement variability, measurement system capability, accuracy, precision, repeatability, reproducibility, and robustness.Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.Strong technical documentation and technical writing skills.Ability to work as a TMV SME/Lead and mentor junior engineers.Must be comfortable working onsite in Newark, Delaware.","datePosted":"2026-08-12T11:06:43.862Z","dateModified":"2026-08-12T11:06:43.862Z","hiringOrganization":{"@type":"Organization","name":"United Pharma Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Newark","addressRegion":"DE","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c38928e66f40d52e4b5cb149"},"url":"https://jobsearcher.com/jobs/c38928e66f40d52e4b5cb149"}}