Staff Engineer, NPI & Transfers (Chemistry)

Position OverviewResponsible for supporting process development and improvements for medical devices for both existing and new product development, production, and processes. This includes working closely with R&D at the early phases of product development to create manufacturing specifications, maintain, and enhance product processes, and design fixtures and equipment, testing processes, equipment, and validate test methods, and select raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, existing process improvement and engineering to improve product quality and yields, and other engineering tasks. Evaluate, initiate, and establish improved engineering and project systems for procurement and execution of process validation. Work with Manufacturing, Quality, Regulatory, and global Marketing teams internally and outside vendors and consultants.Develop new processes and perform process characterization and optimizationSupport improvement for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixturesWork closely with R&D team to design manufacturability and assembly into the product (dFMEA)Characterize process and determine critical process parameters by applying statistical tools such as DoE and ensure readiness for process validationApply statistical process control techniques to establish review and refine control limits for existing processesSupport validation of product, equipment, and processesCollaborate with other departments to ensure readiness for process validationDraft and execute validation of product, equipment, and processesEvaluate, create, and initiate improvements to existing engineering and project systemsAnalyze test data using statistical tools (e.g., Minitab) to inform leadership decisions for enhancing existing processes and improving product quality and yieldManage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planningPlan and execute root cause investigations related to product and process failuresConfer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processesSet up and initiate new manufacturing line(s), including purchasing, implementing, and validating new equipment (IQ/OQ)Support Design Transfer and Line Transfer activities to different manufacturing sitesReview and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.)Develop documentation expertise in equipment mechanical design and manufacturing processesSeek and implement innovative technologies to enhance manufacturing processes and equipment designHelp establish systems for monitoring production processes to identify inefficiencies and develop strategies to reduce waste, improve yield, and enhance product qualityLead, mentor, and support Engineers, Technicians, or others as neededComply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organizationPerform additional duties as assignedJob ID 13488BRSalary Range:$116,706.01-$145,882.52 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)J-18808-Ljbffr