{"schemaVersion":"jobsearcher.job.v1","id":"36a2f33e727f81cfc4690914","url":"https://jobsearcher.com/jobs/36a2f33e727f81cfc4690914","canonicalUrl":"https://jobsearcher.com/jobs/36a2f33e727f81cfc4690914","title":"Process Development Engineer","description":"Responsible for designing, developing, and optimizing manufacturing processes to ensure products are safe, effective, and compliant with regulatory standards.\nKey Responsibilities:\nDevelop and scale up manufacturing processes for new and existing medical devices\nDesign experiments (DOE) to optimize process performance and robustness\nSupport process validation activities (IQ/OQ/PQ) and equipment qualifications\nCollaborate with R&D, Quality, and Regulatory teams to ensure compliance with FDA and ISO requirements (e.g., ISO 13485)\nIdentify and implement process improvements to enhance yield, efficiency, and cost-effectiveness\nTroubleshoot manufacturing issues and lead root cause investigations (e.g., CAPA support)\nGenerate and maintain technical documentation, including protocols, reports, and SOPs\nQualifications:\nBachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field)\nExperience in medical device manufacturing or regulated industry\nKnowledge of validation, risk management, and GMP practices\nFamiliarity with statistical tools and continuous improvement methodologies\nJob Types: Full-time, Contract\nWork Location: In person","company":"Professional Pharma Solutions","rawCompany":"professional pharma solutions","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:25:20.071Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-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":"Responsible for designing, developing, and optimizing manufacturing processes to ensure products are safe, effective, and compliant with regulatory standards.\nKey Responsibilities:\nDevelop and scale up manufacturing processes for new and existing medical devices\nDesign experiments (DOE) to optimize process performance and robustness\nSupport process validation activities (IQ/OQ/PQ) and equipment qualifications\nCollaborate with R&D, Quality, and Regulatory teams to ensure compliance with FDA and ISO requirements (e.g., ISO 13485)\nIdentify and implement process improvements to enhance yield, efficiency, and cost-effectiveness\nTroubleshoot manufacturing issues and lead root cause investigations (e.g., CAPA support)\nGenerate and maintain technical documentation, including protocols, reports, and SOPs\nQualifications:\nBachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field)\nExperience in medical device manufacturing or regulated industry\nKnowledge of validation, risk management, and GMP practices\nFamiliarity with statistical tools and continuous improvement methodologies\nJob Types: Full-time, Contract\nWork Location: In person","datePosted":"2026-04-14T11:25:20.071Z","dateModified":"2026-04-14T11:25:20.071Z","hiringOrganization":{"@type":"Organization","name":"Professional Pharma Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"36a2f33e727f81cfc4690914"},"url":"https://jobsearcher.com/jobs/36a2f33e727f81cfc4690914"}}