Manufacturing Engineer - 205417

ResponsibilitiesIdentify improvement opportunities and implement solutions to reduce process variation, enhance productivity, and minimize scrapDevelop and optimize manufacturing processes through the design and modification of equipment used in fabrication, assembly, and installationProvide cross-functional support to R&D, manufacturing, marketing, and customer service, while interfacing with customers and suppliersApply Six Sigma methodologies to determine critical process parameters and establish monitoring tools that support cost reduction initiativesLead projects within a matrix organization, overseeing all phases from planning through executionIndependently conduct validations and support technicians and engineers in executing IQ, OQ, PQ, and TMV protocolsDrive continuous improvement initiatives to enhance manufacturing capabilityMentor and guide junior engineers and technicians in the development of new products and technologiesSupport strategic initiatives, including product line transfers and related activitiesAssist in the design and development of gauges, fixtures, tooling, and manufacturing methodsPerform design and process FMEAsPartner with value stream teams to implement cost reduction and cost avoidance strategiesQualificationsBachelor's degree in Engineering required, Preferred disciplines: Plastics, Chemical, Biomedical, or Mechanical Engineering, Minimum of 3 years of experience in process development or process improvement within a manufacturing environmentExperience in medical device or other regulated industries (e.g., ISO, FDA) preferred