{"schemaVersion":"jobsearcher.job.v1","id":"021261e9e63bfcbe74a315dd","url":"https://jobsearcher.com/jobs/021261e9e63bfcbe74a315dd","canonicalUrl":"https://jobsearcher.com/jobs/021261e9e63bfcbe74a315dd","title":"Test Method Validation Engineer","description":"TMV Engineer / SMELocation: Newark, DE – OnsiteIndustry: Medical DevicePosition OverviewWe are seeking experienced TMV Engineers / SMEs to support the development, validation, and execution of test methods for complex electromechanical medical device systems. The role will focus heavily on Test Method Validation (TMV), Design Verification, and Design Validation (DV/DV) activities supporting products through commercialization.The TMV Engineer will serve as a technical SME and mentor for TMV specialists, guiding test method development, measurement systems, statistical analysis, validation strategies, and troubleshooting.Key ResponsibilitiesDevelop, optimize, and validate test methods for complex electromechanical medical device systems to verify critical product, clinical, and system performance requirements.Translate design inputs, product requirements, and clinical requirements into robust, repeatable, reproducible, and validation-ready test methods.Develop and execute TMV protocols, test procedures, fixtures, measurement techniques, acceptance criteria, and validation reports.Lead Gauge R&R, Repeatability & Reproducibility (R&R), Measurement System Analysis (MSA), and other statistical assessments.Identify measurement and control requirements and evaluate the suitability and capability of equipment used within test methods.Identify and assess potential sources of variability, determine the need for MSA, and establish appropriate controls to ensure reliable test results.Perform hands-on laboratory testing, data collection, troubleshooting, and statistical analysis in support of Design Verification and Design Validation activities.Analyze TMV data to demonstrate accuracy, precision, repeatability, reproducibility, robustness, and measurement system capability.Prepare and review TMV protocols, reports, test procedures, and supporting technical documentation in compliance with applicable FDA and ISO 13485 requirements.Support execution of test cases required to bring medical device products through verification, validation, and commercialization.Troubleshoot test-method issues and work cross-functionally with R&D, Design Engineering, Quality, Manufacturing, Clinical, and Regulatory teams.Serve as the TMV SME/technical lead, providing guidance and mentorship to junior TMV engineers and specialists.Required QualificationsStrong hands-on experience in Test Method Validation (TMV) for medical devices.Experience supporting Design Verification (DV) and Design Validation (DVT/DV&V) activities.Experience with Gauge R&R, MSA, repeatability/reproducibility, statistical analysis, and measurement-system characterization.Experience developing TMV protocols, test methods, acceptance criteria, and validation reports.Strong understanding of measurement systems, test equipment, fixtures, instrumentation, and sources of test-method variability.Experience with electromechanical medical devices or similarly complex regulated products.Working knowledge of FDA 21 CFR Part 820, ISO 13485, and Design Control requirements.Strong troubleshooting, technical documentation, and laboratory testing skills.Ability to operate as a hands-on technical SME and mentor for other engineers.","company":"United Pharma Technologies","rawCompany":"united pharma technologies","city":"Delaware City","state":"DE","isRemote":false,"isActive":false,"createdAt":"2026-08-15T09:38:16.414Z","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":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Test Method Validation Engineer","description":"TMV Engineer / SMELocation: Newark, DE – OnsiteIndustry: Medical DevicePosition OverviewWe are seeking experienced TMV Engineers / SMEs to support the development, validation, and execution of test methods for complex electromechanical medical device systems. The role will focus heavily on Test Method Validation (TMV), Design Verification, and Design Validation (DV/DV) activities supporting products through commercialization.The TMV Engineer will serve as a technical SME and mentor for TMV specialists, guiding test method development, measurement systems, statistical analysis, validation strategies, and troubleshooting.Key ResponsibilitiesDevelop, optimize, and validate test methods for complex electromechanical medical device systems to verify critical product, clinical, and system performance requirements.Translate design inputs, product requirements, and clinical requirements into robust, repeatable, reproducible, and validation-ready test methods.Develop and execute TMV protocols, test procedures, fixtures, measurement techniques, acceptance criteria, and validation reports.Lead Gauge R&R, Repeatability & Reproducibility (R&R), Measurement System Analysis (MSA), and other statistical assessments.Identify measurement and control requirements and evaluate the suitability and capability of equipment used within test methods.Identify and assess potential sources of variability, determine the need for MSA, and establish appropriate controls to ensure reliable test results.Perform hands-on laboratory testing, data collection, troubleshooting, and statistical analysis in support of Design Verification and Design Validation activities.Analyze TMV data to demonstrate accuracy, precision, repeatability, reproducibility, robustness, and measurement system capability.Prepare and review TMV protocols, reports, test procedures, and supporting technical documentation in compliance with applicable FDA and ISO 13485 requirements.Support execution of test cases required to bring medical device products through verification, validation, and commercialization.Troubleshoot test-method issues and work cross-functionally with R&D, Design Engineering, Quality, Manufacturing, Clinical, and Regulatory teams.Serve as the TMV SME/technical lead, providing guidance and mentorship to junior TMV engineers and specialists.Required QualificationsStrong hands-on experience in Test Method Validation (TMV) for medical devices.Experience supporting Design Verification (DV) and Design Validation (DVT/DV&V) activities.Experience with Gauge R&R, MSA, repeatability/reproducibility, statistical analysis, and measurement-system characterization.Experience developing TMV protocols, test methods, acceptance criteria, and validation reports.Strong understanding of measurement systems, test equipment, fixtures, instrumentation, and sources of test-method variability.Experience with electromechanical medical devices or similarly complex regulated products.Working knowledge of FDA 21 CFR Part 820, ISO 13485, and Design Control requirements.Strong troubleshooting, technical documentation, and laboratory testing skills.Ability to operate as a hands-on technical SME and mentor for other engineers.","datePosted":"2026-08-15T09:38:16.414Z","dateModified":"2026-08-15T09:38:16.414Z","hiringOrganization":{"@type":"Organization","name":"United Pharma Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Delaware City","addressRegion":"DE","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"021261e9e63bfcbe74a315dd"},"url":"https://jobsearcher.com/jobs/021261e9e63bfcbe74a315dd"}}