{"schemaVersion":"jobsearcher.job.v1","id":"3d89f75f3e0b4611d1370e0a","url":"https://jobsearcher.com/jobs/3d89f75f3e0b4611d1370e0a","canonicalUrl":"https://jobsearcher.com/jobs/3d89f75f3e0b4611d1370e0a","title":"Lead Process Development Engineer","description":"The Lead Process Engineer will lead the development, validation, transfer, and optimization of manufacturing processes supporting medical device products. This individual will serve as a technical leader responsible for process characterization, risk management, equipment qualification, manufacturing scale‑up, and continuous improvement initiatives across internal manufacturing operations and external suppliers.\nThe ideal candidate will have extensive experience in regulated manufacturing environments and a proven track record of successfully bringing processes from development through commercial production while ensuring compliance with FDA and ISO standards.\nRequired Experience Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related technical discipline\n10+ years of process engineering experience within medical device, pharmaceutical, or other FDA regulated environment\nWorking knowledge of FDA 21 CFR Part820 and ISO13485 requirements\nStrong experience with process development, characterization, validation, and continuous improvement\nHands‑on expertise executing IQ/OQ/PQ process validations and authoring validation protocols and reports\nExperience leading Process FMEA activities, risk assessments, and root cause investigations\nPreferred Experience Experience supporting manufacturing transfers, supplier process development, and new product introductions\nStrong analytical and statistical problem‑solving skills with experience utilizing Lean Manufacturing and Six Sigma methodologies\nAbility to troubleshoot complex manufacturing processes and implement sustainable corrective actions\nSterilization and packaging validation experience\nMinitab proficiency and process capability analysis\nFixture and tooling design experience\nLean Six Sigma certification\nExperience with Microsoft Dynamics365 or similar ERP systems\n\n#J-18808-Ljbffr","company":"Interactive Resources","rawCompany":"interactive resources","city":"Huntersville","state":"NC","isRemote":false,"isActive":true,"createdAt":"2026-06-23T03:20:14.166Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Process Development Engineer","description":"The Lead Process Engineer will lead the development, validation, transfer, and optimization of manufacturing processes supporting medical device products. This individual will serve as a technical leader responsible for process characterization, risk management, equipment qualification, manufacturing scale‑up, and continuous improvement initiatives across internal manufacturing operations and external suppliers.\nThe ideal candidate will have extensive experience in regulated manufacturing environments and a proven track record of successfully bringing processes from development through commercial production while ensuring compliance with FDA and ISO standards.\nRequired Experience Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related technical discipline\n10+ years of process engineering experience within medical device, pharmaceutical, or other FDA regulated environment\nWorking knowledge of FDA 21 CFR Part820 and ISO13485 requirements\nStrong experience with process development, characterization, validation, and continuous improvement\nHands‑on expertise executing IQ/OQ/PQ process validations and authoring validation protocols and reports\nExperience leading Process FMEA activities, risk assessments, and root cause investigations\nPreferred Experience Experience supporting manufacturing transfers, supplier process development, and new product introductions\nStrong analytical and statistical problem‑solving skills with experience utilizing Lean Manufacturing and Six Sigma methodologies\nAbility to troubleshoot complex manufacturing processes and implement sustainable corrective actions\nSterilization and packaging validation experience\nMinitab proficiency and process capability analysis\nFixture and tooling design experience\nLean Six Sigma certification\nExperience with Microsoft Dynamics365 or similar ERP systems\n\n#J-18808-Ljbffr","datePosted":"2026-06-23T03:20:14.166Z","dateModified":"2026-06-23T03:20:14.166Z","hiringOrganization":{"@type":"Organization","name":"Interactive Resources","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Huntersville","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3d89f75f3e0b4611d1370e0a"},"url":"https://jobsearcher.com/jobs/3d89f75f3e0b4611d1370e0a"}}