Process Engineer Development Improvement

Overview In 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. ResponsibilitiesDesign 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 Key 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