{"schemaVersion":"jobsearcher.job.v1","id":"0565c7477ca93374660edd3f","url":"https://jobsearcher.com/jobs/0565c7477ca93374660edd3f","canonicalUrl":"https://jobsearcher.com/jobs/0565c7477ca93374660edd3f","title":"Process Development Engineer","description":"We are seeking a skilled Process Development Engineer with experience in the Medical Device or Pharmaceutical industry to support the development, optimization, and validation of manufacturing processes for drug/device combination products. This role is ideal for candidates with strong expertise in packaging, assembly processes, and working within regulated environments.\n\nPosition Summary\nYou will play a key role in driving process development activities from concept through commercialization. The position requires hands‑on involvement in process characterization, validation, and continuous improvement while ensuring compliance with FDA and quality standards.\n\nKey Responsibilities\n\nDevelop, optimize, and validate manufacturing processes for medical devices, pharmaceutical products, and combination products\n\nLead process development activities for packaging and assembly operations\n\nDesign and execute DOE (Design of Experiments) for process characterization and optimization\n\nPerform risk assessments using FMEA methodologies\n\nDevelop and implement SPC strategies for process monitoring and control\n\nAuthor and execute IQ, OQ, PQ validation protocols and reports\n\nSupport design verification and validation activities\n\nApply Design Control principles throughout the product lifecycle\n\nCreate technical documentation including protocols, reports, and work instructions\n\nCollaborate with cross‑functional teams such as R&D, Quality, Manufacturing, Regulatory, and Supply Chain\n\nBuild and evaluate prototypes to support development activities\n\nTroubleshoot manufacturing issues and drive CAPA activities\n\nEnsure compliance with FDA regulations, GMP, ISO 13485, and quality standards\n\nRequired Qualifications\n\nBachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering\n\n3+ years of experience in process development within Medical Device or Pharma industry\n\nStrong experience in packaging and assembly processes\n\nHands‑on experience with FMEA, DOE, SPC, Design Controls, and IQ/OQ/PQ validation\n\nExperience with Verification and Validation (V&V)\n\nStrong documentation and technical writing skills\n\nKnowledge of FDA regulations, GMP, and ISO 13485\n\nStrong analytical and problem‑solving skills\n\nPreferred Qualifications\n\nExperience with drug/device combination products\n\nExperience supporting New Product Development (NPD)\n\nKnowledge of Lean Manufacturing and Six Sigma methodologies\n\nFamiliarity with CAPA, change control, and risk management processes\n\nExperience working in regulated manufacturing environments\n\n#J-18808-Ljbffr","company":"Shoolin","rawCompany":"shoolin","city":"Brooklyn","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-07-18T03:17:04.777Z","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":"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":"We are seeking a skilled Process Development Engineer with experience in the Medical Device or Pharmaceutical industry to support the development, optimization, and validation of manufacturing processes for drug/device combination products. This role is ideal for candidates with strong expertise in packaging, assembly processes, and working within regulated environments.\n\nPosition Summary\nYou will play a key role in driving process development activities from concept through commercialization. The position requires hands‑on involvement in process characterization, validation, and continuous improvement while ensuring compliance with FDA and quality standards.\n\nKey Responsibilities\n\nDevelop, optimize, and validate manufacturing processes for medical devices, pharmaceutical products, and combination products\n\nLead process development activities for packaging and assembly operations\n\nDesign and execute DOE (Design of Experiments) for process characterization and optimization\n\nPerform risk assessments using FMEA methodologies\n\nDevelop and implement SPC strategies for process monitoring and control\n\nAuthor and execute IQ, OQ, PQ validation protocols and reports\n\nSupport design verification and validation activities\n\nApply Design Control principles throughout the product lifecycle\n\nCreate technical documentation including protocols, reports, and work instructions\n\nCollaborate with cross‑functional teams such as R&D, Quality, Manufacturing, Regulatory, and Supply Chain\n\nBuild and evaluate prototypes to support development activities\n\nTroubleshoot manufacturing issues and drive CAPA activities\n\nEnsure compliance with FDA regulations, GMP, ISO 13485, and quality standards\n\nRequired Qualifications\n\nBachelor’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering\n\n3+ years of experience in process development within Medical Device or Pharma industry\n\nStrong experience in packaging and assembly processes\n\nHands‑on experience with FMEA, DOE, SPC, Design Controls, and IQ/OQ/PQ validation\n\nExperience with Verification and Validation (V&V)\n\nStrong documentation and technical writing skills\n\nKnowledge of FDA regulations, GMP, and ISO 13485\n\nStrong analytical and problem‑solving skills\n\nPreferred Qualifications\n\nExperience with drug/device combination products\n\nExperience supporting New Product Development (NPD)\n\nKnowledge of Lean Manufacturing and Six Sigma methodologies\n\nFamiliarity with CAPA, change control, and risk management processes\n\nExperience working in regulated manufacturing environments\n\n#J-18808-Ljbffr","datePosted":"2026-07-18T03:17:04.777Z","dateModified":"2026-07-18T03:17:04.777Z","hiringOrganization":{"@type":"Organization","name":"Shoolin","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0565c7477ca93374660edd3f"},"url":"https://jobsearcher.com/jobs/0565c7477ca93374660edd3f"}}