Staff Engineer, NPI & Transfers

Responsible 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. Job duties:

• Develop new processes and perform process characterization and optimization.
• Support improvement for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures.
• Work 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 validation.
• Apply statistical process control techniques to establish review and refine control limits for existing processes.
• Support validation of product, equipment, and processes.
• Collaborate with other departments to ensure readiness for process validation.
• Draft and execute validation of product, equipment, and processes.
• Evaluate, create, and initiate improvements to existing engineering and project systems.
• Analyze test data using statistical tools (e.g., Minitab) to inform leadership decisions for enhancing existing processes and improving product quality and yield.
• Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
• Plan and execute root cause investigations related to product and process failures.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Set 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 sites.
• Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.).
• Develop documentation expertise in equipment mechanical design and manufacturing processes.
• Seek and implement innovative technologies to enhance manufacturing processes and equipment design.
• Help establish systems for monitoring production processes to identify inefficiencies and develop strategies to reduce waste, improve yield, and enhance product quality.
• Lead, mentor, and support Engineers, Technicians, or others as needed.
• Comply 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 organization.
• Perform additional duties as assigned.