{"schemaVersion":"jobsearcher.job.v1","id":"7b09409bedbb689c519b7819","url":"https://jobsearcher.com/jobs/7b09409bedbb689c519b7819","canonicalUrl":"https://jobsearcher.com/jobs/7b09409bedbb689c519b7819","title":"Process Development Engineer","description":"Responsible for developing, validating, and sustaining manufacturing processes and equipment used in medical device production. This role ensures products can be reliably transitioned from design to scalable production through process development, tooling/fixture design, validation (IQ/OQ/PQ), and cross‑functional support. The engineer will also support production transfers, supplier manufacturing, and process improvement activities while ensuring compliance with FDA and ISO requirements.\nRequired Experience Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field\n3+ years of experience in medical device or pharmaceutical manufacturing\nHands‑on experience with process development, process flow design, and manufacturing documentation\nExperience executing or supporting validation activities (IQ/OQ/PQ)\nKnowledge of FDA 21 CFR Part 820 and ISO 13485 requirements\nExperience developing or supporting process FMEAs and risk management activities\nAbility to create and maintain work instructions, process documentation, and technical reports\nExperience supporting production troubleshooting and manufacturing issue resolution\nProficiency in Microsoft Office and strong documentation skills\nPreferred Experience Experience with production transfers from R&D to manufacturing\nExposure to fixture/tooling design and manufacturing equipment development\nExperience with CAD tools (SolidWorks, Solid Edge, or similar)\nFamiliarity with Lean Manufacturing principles and continuous improvement\nExperience working with suppliers or contract manufacturers\nKnowledge of process capability analysis and validation protocols\nStrong cross‑functional collaboration with Quality, R&D, and Operations teams\n\n#J-18808-Ljbffr","company":"Interactive Resources","rawCompany":"interactive resources","city":"Huntersville","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-06-23T03:20:12.494Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-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":"Process Development Engineer","description":"Responsible for developing, validating, and sustaining manufacturing processes and equipment used in medical device production. This role ensures products can be reliably transitioned from design to scalable production through process development, tooling/fixture design, validation (IQ/OQ/PQ), and cross‑functional support. The engineer will also support production transfers, supplier manufacturing, and process improvement activities while ensuring compliance with FDA and ISO requirements.\nRequired Experience Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field\n3+ years of experience in medical device or pharmaceutical manufacturing\nHands‑on experience with process development, process flow design, and manufacturing documentation\nExperience executing or supporting validation activities (IQ/OQ/PQ)\nKnowledge of FDA 21 CFR Part 820 and ISO 13485 requirements\nExperience developing or supporting process FMEAs and risk management activities\nAbility to create and maintain work instructions, process documentation, and technical reports\nExperience supporting production troubleshooting and manufacturing issue resolution\nProficiency in Microsoft Office and strong documentation skills\nPreferred Experience Experience with production transfers from R&D to manufacturing\nExposure to fixture/tooling design and manufacturing equipment development\nExperience with CAD tools (SolidWorks, Solid Edge, or similar)\nFamiliarity with Lean Manufacturing principles and continuous improvement\nExperience working with suppliers or contract manufacturers\nKnowledge of process capability analysis and validation protocols\nStrong cross‑functional collaboration with Quality, R&D, and Operations teams\n\n#J-18808-Ljbffr","datePosted":"2026-06-23T03:20:12.494Z","dateModified":"2026-06-23T03:20:12.494Z","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":"7b09409bedbb689c519b7819"},"url":"https://jobsearcher.com/jobs/7b09409bedbb689c519b7819"}}