{"schemaVersion":"jobsearcher.job.v1","id":"f14465815d43a5e1cab295e0","url":"https://jobsearcher.com/jobs/f14465815d43a5e1cab295e0","canonicalUrl":"https://jobsearcher.com/jobs/f14465815d43a5e1cab295e0","title":"Process Engineer Development Improvement","description":"Overview\nIn this contract role, you apply extensive experience in product development, sustaining, and regulatory compliance to FDA requirements for medical devices. You will design tooling and equipment, oversee validation and verification, and drive process development, scale‑up, and manufacturing troubleshooting. You’ll establish and improve QA and technology transfer procedures, while pursuing cost improvements and process optimization. You will collaborate across sites and suppliers to support compliant manufacturing.\n\nResponsibilitiesDesign and specify tooling and equipment; oversee validation and verificationDevelop process development, scale-up, and manufacturing troubleshootingEstablish contractor sites of manufacture and packaging supplier networksSignificantly improve the QA system and technical transfer procedureProvide cost improvement projects and process optimizationSupport compliance with FDA regulations and cGMPs; implement ISO 13485 frameworks\nKey requirementsExtensive experience in product development, sustaining, and compliance to FDA regulationsExperience with Class I and II medical devicesExperience implementing structures following cGMPs for medical devices using ISO 13485CAPA investigation experience (preferred)Six Sigma Green Belt (preferred)FDA compliancecGMPISO 13485CAPASix Sigma (Green Belt, preferred)process validation and verification","company":"System Canada Technologies","rawCompany":"system canada technologies","city":"Somerville","state":"MA","isRemote":false,"isActive":true,"createdAt":"2026-09-15T04:44:04.567Z","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":"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"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer Development Improvement","description":"Overview\nIn this contract role, you apply extensive experience in product development, sustaining, and regulatory compliance to FDA requirements for medical devices. You will design tooling and equipment, oversee validation and verification, and drive process development, scale‑up, and manufacturing troubleshooting. You’ll establish and improve QA and technology transfer procedures, while pursuing cost improvements and process optimization. You will collaborate across sites and suppliers to support compliant manufacturing.\n\nResponsibilitiesDesign and specify tooling and equipment; oversee validation and verificationDevelop process development, scale-up, and manufacturing troubleshootingEstablish contractor sites of manufacture and packaging supplier networksSignificantly improve the QA system and technical transfer procedureProvide cost improvement projects and process optimizationSupport compliance with FDA regulations and cGMPs; implement ISO 13485 frameworks\nKey requirementsExtensive experience in product development, sustaining, and compliance to FDA regulationsExperience with Class I and II medical devicesExperience implementing structures following cGMPs for medical devices using ISO 13485CAPA investigation experience (preferred)Six Sigma Green Belt (preferred)FDA compliancecGMPISO 13485CAPASix Sigma (Green Belt, preferred)process validation and verification","datePosted":"2026-09-15T04:44:04.567Z","dateModified":"2026-09-15T04:44:04.567Z","hiringOrganization":{"@type":"Organization","name":"System Canada Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Somerville","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f14465815d43a5e1cab295e0"},"url":"https://jobsearcher.com/jobs/f14465815d43a5e1cab295e0"}}