{"schemaVersion":"jobsearcher.job.v1","id":"421642f7859e0cbb7db25793","url":"https://jobsearcher.com/jobs/421642f7859e0cbb7db25793","canonicalUrl":"https://jobsearcher.com/jobs/421642f7859e0cbb7db25793","title":"Process Development Engineer","description":"Role Summary\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\nKey Responsibilities\nSupport IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\nDesign and develop in‑process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation; collaborate with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\nWork with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\nExperience Requirements\n5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).\nStrong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root‑cause investigation.\nExperience supporting new product introductions and process scale‑up.\nQuality Expectations\nDemonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.\nEnsures proper documentation discipline and supports Quality System compliance.\n\nSpecial requirement:\n3.00 GPA minimum\nRUM or Polytechnic University graduates\nBS in Engineering\n**Weil Group is proud to be an Equal Employment Opportunity Employer.*","company":"Weil Group","rawCompany":"weil group","city":"Dorado","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:14:25.494Z","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":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-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":"Role Summary\nThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.\nKey Responsibilities\nSupport IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.\nDesign and develop in‑process and receiving inspection systems for new components and processes.\nGenerate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.\nManage process development projects from concept through implementation; collaborate with cross-functional teams.\nApply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.\nWork with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).\nExperience Requirements\n5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).\nStrong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.\nElectrical and mechanical engineering background applied to automated manufacturing systems.\nExperience with automation/controls, tooling, fixtures, test method development, and equipment qualification.\nProficiency in DOE, FMEA, CAPA, and root‑cause investigation.\nExperience supporting new product introductions and process scale‑up.\nQuality Expectations\nDemonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.\nEnsures proper documentation discipline and supports Quality System compliance.\n\nSpecial requirement:\n3.00 GPA minimum\nRUM or Polytechnic University graduates\nBS in Engineering\n**Weil Group is proud to be an Equal Employment Opportunity Employer.*","datePosted":"2026-04-14T11:14:25.494Z","dateModified":"2026-04-14T11:14:25.494Z","hiringOrganization":{"@type":"Organization","name":"Weil Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dorado","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"421642f7859e0cbb7db25793"},"url":"https://jobsearcher.com/jobs/421642f7859e0cbb7db25793"}}