{"schemaVersion":"jobsearcher.job.v1","id":"7a65b2ac418f787ec148dd98","url":"https://jobsearcher.com/jobs/7a65b2ac418f787ec148dd98","canonicalUrl":"https://jobsearcher.com/jobs/7a65b2ac418f787ec148dd98","title":"Validation Engineer","description":"We are seeking a Mechanical Product Validation Engineer with hands‑on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will support product development by developing and executing validation studies, creating test methods, performing root cause analysis, and collaborating with cross‑functional teams to ensure regulatory compliance and successful product launches.\nKey Responsibilities Develop soiling, cleaning, and extraction processes for reusable medical devices, including scopes, instruments, and accessories.\nPlan, execute, and analyze Cleaning & Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validation activities.\nDevelop and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies, and prepare validation protocols, reports, and statistical analyses.\nInvestigate cleaning and sterilization process issues using root cause analysis and recommend corrective actions.\nSupport risk management activities, including DFMEA, PFMEA, and Hazard Analysis , by providing technical input and laboratory expertise.\nParticipate in Design Reviews and Phase Exit Reviews , preparing technical documentation and presenting validation results.\nCollaborate with R&D, Quality, Regulatory, Manufacturing, and external testing laboratories to support product development and commercialization.\nEnsure validation activities comply with quality standards, regulatory requirements, and project timelines.\nRequired Qualifications Bachelor's degree in Mechanical Engineering or equivalent.\nMinimum 5+ years of experience in mechanical product validation , preferably within the medical device industry .\nHands‑on experience with cleaning, sterilization, and reprocessing validation of reusable medical devices.\nExperience developing test methods, executing validation studies, and performing GR&R .\nStrong knowledge of root cause analysis , statistical analysis, and engineering documentation.\nExperience supporting risk management activities, including DFMEA, PFMEA, and Hazard Analysis .\nStrong communication and cross‑functional collaboration skills.\nPreferred Qualifications Experience with reusable endoscopes, surgical instruments, or similar medical devices.\nKnowledge of medical device design controls, verification, and validation processes.\nExperience working with external testing laboratories and sterilization service providers.\nFamiliarity with FDA and ISO standards related to reusable medical devices.\nStrong analytical, problem‑solving, and presentation skills.\n\n#J-18808-Ljbffr","company":"Pentangle Tech Services","rawCompany":"pentangle tech services p5 group","city":"Brooklyn","state":"NY","isRemote":false,"isActive":true,"createdAt":"2026-08-13T03:41:58.782Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"We are seeking a Mechanical Product Validation Engineer with hands‑on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will support product development by developing and executing validation studies, creating test methods, performing root cause analysis, and collaborating with cross‑functional teams to ensure regulatory compliance and successful product launches.\nKey Responsibilities Develop soiling, cleaning, and extraction processes for reusable medical devices, including scopes, instruments, and accessories.\nPlan, execute, and analyze Cleaning & Sterilization (C&S) feasibility studies, cleanability assessments, and sterilization validation activities.\nDevelop and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies, and prepare validation protocols, reports, and statistical analyses.\nInvestigate cleaning and sterilization process issues using root cause analysis and recommend corrective actions.\nSupport risk management activities, including DFMEA, PFMEA, and Hazard Analysis , by providing technical input and laboratory expertise.\nParticipate in Design Reviews and Phase Exit Reviews , preparing technical documentation and presenting validation results.\nCollaborate with R&D, Quality, Regulatory, Manufacturing, and external testing laboratories to support product development and commercialization.\nEnsure validation activities comply with quality standards, regulatory requirements, and project timelines.\nRequired Qualifications Bachelor's degree in Mechanical Engineering or equivalent.\nMinimum 5+ years of experience in mechanical product validation , preferably within the medical device industry .\nHands‑on experience with cleaning, sterilization, and reprocessing validation of reusable medical devices.\nExperience developing test methods, executing validation studies, and performing GR&R .\nStrong knowledge of root cause analysis , statistical analysis, and engineering documentation.\nExperience supporting risk management activities, including DFMEA, PFMEA, and Hazard Analysis .\nStrong communication and cross‑functional collaboration skills.\nPreferred Qualifications Experience with reusable endoscopes, surgical instruments, or similar medical devices.\nKnowledge of medical device design controls, verification, and validation processes.\nExperience working with external testing laboratories and sterilization service providers.\nFamiliarity with FDA and ISO standards related to reusable medical devices.\nStrong analytical, problem‑solving, and presentation skills.\n\n#J-18808-Ljbffr","datePosted":"2026-08-13T03:41:58.782Z","dateModified":"2026-08-13T03:41:58.782Z","hiringOrganization":{"@type":"Organization","name":"Pentangle Tech Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7a65b2ac418f787ec148dd98"},"url":"https://jobsearcher.com/jobs/7a65b2ac418f787ec148dd98"}}