{"schemaVersion":"jobsearcher.job.v1","id":"c3d586f76cf526de33ad3edf","url":"https://jobsearcher.com/jobs/c3d586f76cf526de33ad3edf","canonicalUrl":"https://jobsearcher.com/jobs/c3d586f76cf526de33ad3edf","title":"Process Development Engineer","description":"They're looking for a Process Development Engineer who can take a product from development into manufacturing\n\nJob Title\nProcess Development Engineer (Medical Device / Pharma)\n\nLocation\nOhio (Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)\n\nDuration\n12+ Months Contract\n\nExperience\n5+\n\nSummary\nWe are seeking a Process Development Engineer with a strong background in Medical Devices, Pharmaceuticals, or Combination Products to support process development, validation, and manufacturing activities. The ideal candidate will have hands‑on experience in packaging and assembly processes, process optimization, and product development within a regulated environment. This role requires close collaboration with cross‑functional teams to ensure robust manufacturing processes that meet quality and regulatory requirements.\n\nKey Responsibilities\n\nDevelop, optimize, and implement manufacturing processes for medical devices, pharmaceutical products, or combination products.\n\nSupport packaging and assembly process development from concept through commercialization.\n\nConduct Failure Mode and Effects Analysis (FMEA) to identify and mitigate process risks.\n\nDesign and execute Design of Experiments (DOE) for process optimization and continuous improvement.\n\nUtilize Statistical Process Control (SPC) tools to monitor process performance and drive quality improvements.\n\nSupport Design Control activities throughout the product development lifecycle.\n\nPlan and execute equipment and process validation activities, including IQ, OQ, and PQ protocols.\n\nPrepare and review validation protocols, reports, engineering documentation, and technical reports.\n\nDevelop prototypes and support engineering builds for new product introductions.\n\nPerform verification and validation testing to ensure product and process compliance.\n\nCollaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams.\n\nEnsure compliance with FDA regulations, ISO 13485, 14971 standards, and Good Manufacturing Practices (GMP).\n\nRequired Qualifications\n\nBachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or a related engineering discipline.\n\nExperience in the Medical Device, Pharmaceutical, or Combination Product industry.\n\nHands‑on experience with packaging and assembly process development.\n\nPreferred Qualifications\n\nExperience supporting new product introduction (NPI).\n\nKnowledge of Lean Manufacturing or Six Sigma methodologies.\n\nFamiliarity with ISO 13485 and FDA 21 CFR Part 820 (or applicable Quality Management System regulations).\n\nExperience with risk management and product lifecycle documentation.\n\n#J-18808-Ljbffr","company":"Fusion Life Sciences Technologies","rawCompany":"fusion life sciences technologies","city":"Brooklyn","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:41:17.899Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer","description":"They're looking for a Process Development Engineer who can take a product from development into manufacturing\n\nJob Title\nProcess Development Engineer (Medical Device / Pharma)\n\nLocation\nOhio (Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)\n\nDuration\n12+ Months Contract\n\nExperience\n5+\n\nSummary\nWe are seeking a Process Development Engineer with a strong background in Medical Devices, Pharmaceuticals, or Combination Products to support process development, validation, and manufacturing activities. The ideal candidate will have hands‑on experience in packaging and assembly processes, process optimization, and product development within a regulated environment. This role requires close collaboration with cross‑functional teams to ensure robust manufacturing processes that meet quality and regulatory requirements.\n\nKey Responsibilities\n\nDevelop, optimize, and implement manufacturing processes for medical devices, pharmaceutical products, or combination products.\n\nSupport packaging and assembly process development from concept through commercialization.\n\nConduct Failure Mode and Effects Analysis (FMEA) to identify and mitigate process risks.\n\nDesign and execute Design of Experiments (DOE) for process optimization and continuous improvement.\n\nUtilize Statistical Process Control (SPC) tools to monitor process performance and drive quality improvements.\n\nSupport Design Control activities throughout the product development lifecycle.\n\nPlan and execute equipment and process validation activities, including IQ, OQ, and PQ protocols.\n\nPrepare and review validation protocols, reports, engineering documentation, and technical reports.\n\nDevelop prototypes and support engineering builds for new product introductions.\n\nPerform verification and validation testing to ensure product and process compliance.\n\nCollaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams.\n\nEnsure compliance with FDA regulations, ISO 13485, 14971 standards, and Good Manufacturing Practices (GMP).\n\nRequired Qualifications\n\nBachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or a related engineering discipline.\n\nExperience in the Medical Device, Pharmaceutical, or Combination Product industry.\n\nHands‑on experience with packaging and assembly process development.\n\nPreferred Qualifications\n\nExperience supporting new product introduction (NPI).\n\nKnowledge of Lean Manufacturing or Six Sigma methodologies.\n\nFamiliarity with ISO 13485 and FDA 21 CFR Part 820 (or applicable Quality Management System regulations).\n\nExperience with risk management and product lifecycle documentation.\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:41:17.899Z","dateModified":"2026-07-16T03:41:17.899Z","hiringOrganization":{"@type":"Organization","name":"Fusion Life Sciences Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c3d586f76cf526de33ad3edf"},"url":"https://jobsearcher.com/jobs/c3d586f76cf526de33ad3edf"}}