{"schemaVersion":"jobsearcher.job.v1","id":"f078e19250e2c2d713ef73e5","url":"https://jobsearcher.com/jobs/f078e19250e2c2d713ef73e5","canonicalUrl":"https://jobsearcher.com/jobs/f078e19250e2c2d713ef73e5","title":"Process Development Engineer","description":"They're looking for a Process Development Engineer who can take a product from development into manufacturingJob Title: Process Development Engineer (Medical Device / Pharma)Location: Ohio ( Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)Duration: 12+ Months ContractExperience: 5+Summary:We 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.Key Responsibilities* Develop, optimize, and implement manufacturing processes for medical devices, pharmaceutical products, or combination products.* Support packaging and assembly process development from concept through commercialization.* Conduct Failure Mode and Effects Analysis (FMEA to identify and mitigate process risks.* Design and execute Design of Experiments (DOE for process optimization and continuous improvement.* Utilize Statistical Process Control (SPC) tools to monitor process performance and drive quality improvements.* Support Design Control activities throughout the product development lifecycle.* Plan and execute equipment and process validation activities, including IQ, OQ, and PQ protocols.* Prepare and review validation protocols, reports, engineering documentation, and technical reports.* Develop prototypes and support engineering builds for new product introductions.* Perform verification and validation testing to ensure product and process compliance.* Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams.* Ensure compliance with FDA regulations, ISO 13485, 14971 standards, and Good Manufacturing Practices (GMP).Required Qualifications* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or a related engineering discipline.* Experience in the Medical Device, Pharmaceutical, or Combination Product industry.* Hands-on experience with packaging and assembly process development.Preferred Qualifications* Experience supporting new product introduction (NPI).* Knowledge of Lean Manufacturing or Six Sigma methodologies.* Familiarity with ISO 13485 and FDA 21 CFR Part 820 (or applicable Quality Management System regulations).* Experience with risk management and product lifecycle documentation.","company":"Fusion Life Sciences Technologies","rawCompany":"fusion life sciences technologies","city":"Oh","state":"EN","isRemote":false,"isActive":false,"createdAt":"2026-07-11T12:40:58.155Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-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 manufacturingJob Title: Process Development Engineer (Medical Device / Pharma)Location: Ohio ( Cleveland or Dayton or Columbus or Cincinnati/Mason or Broadview Heights)Duration: 12+ Months ContractExperience: 5+Summary:We 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.Key Responsibilities* Develop, optimize, and implement manufacturing processes for medical devices, pharmaceutical products, or combination products.* Support packaging and assembly process development from concept through commercialization.* Conduct Failure Mode and Effects Analysis (FMEA to identify and mitigate process risks.* Design and execute Design of Experiments (DOE for process optimization and continuous improvement.* Utilize Statistical Process Control (SPC) tools to monitor process performance and drive quality improvements.* Support Design Control activities throughout the product development lifecycle.* Plan and execute equipment and process validation activities, including IQ, OQ, and PQ protocols.* Prepare and review validation protocols, reports, engineering documentation, and technical reports.* Develop prototypes and support engineering builds for new product introductions.* Perform verification and validation testing to ensure product and process compliance.* Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams.* Ensure compliance with FDA regulations, ISO 13485, 14971 standards, and Good Manufacturing Practices (GMP).Required Qualifications* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or a related engineering discipline.* Experience in the Medical Device, Pharmaceutical, or Combination Product industry.* Hands-on experience with packaging and assembly process development.Preferred Qualifications* Experience supporting new product introduction (NPI).* Knowledge of Lean Manufacturing or Six Sigma methodologies.* Familiarity with ISO 13485 and FDA 21 CFR Part 820 (or applicable Quality Management System regulations).* Experience with risk management and product lifecycle documentation.","datePosted":"2026-07-11T12:40:58.155Z","dateModified":"2026-07-11T12:40:58.155Z","hiringOrganization":{"@type":"Organization","name":"Fusion Life Sciences Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Oh","addressRegion":"EN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f078e19250e2c2d713ef73e5"},"url":"https://jobsearcher.com/jobs/f078e19250e2c2d713ef73e5"}}