{"schemaVersion":"jobsearcher.job.v1","id":"174d3f5618063cd54f194cf0","url":"https://jobsearcher.com/jobs/174d3f5618063cd54f194cf0","canonicalUrl":"https://jobsearcher.com/jobs/174d3f5618063cd54f194cf0","title":"Senior Process Engineer","description":"The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process\nvalidation, documentation generation, process optimization, and cross-functional technical collaboration.\nResponsibilities\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).\nRequirements\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.","company":"Sharetech Group Engineering","rawCompany":"sharetech group engineering","city":"Caguas","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-14T11:11:47.842Z","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":"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":"Senior Process Engineer","description":"The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process\nvalidation, documentation generation, process optimization, and cross-functional technical collaboration.\nResponsibilities\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).\nRequirements\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.","datePosted":"2026-04-14T11:11:47.842Z","dateModified":"2026-04-14T11:11:47.842Z","hiringOrganization":{"@type":"Organization","name":"Sharetech Group Engineering","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Caguas","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"174d3f5618063cd54f194cf0"},"url":"https://jobsearcher.com/jobs/174d3f5618063cd54f194cf0"}}