Staff Engineer - Product & Process Design

Overview

Staff Engineer - Product & Process Design. With direction from the GIE PPD Leader for UCC, provide a leading Product & Process Design role in planning and execution of medical device projects for the Urology and Critical Care (UCC) Business Unit. Provide product design feedback and serve as the assembly subject matter expert (SME) for cross-functional teams. Capable of specifying process technology, maintaining timelines and project budgets, and actively de-risking all aspects of product and process development.

Requires regular updates to supporting management, cross-function teams, and BU Operational leadership. Travel up to 25% (may be unevenly distributed).

This position will require 25% travel that can be unevenly distributed throughout the year and can exceed 25% when business requirements are needed.

• Define manufacturing technology strategy for new products, support product design by manufacturability analysis of the devices and their packaging and ensure a successful transfer to the production floor.
• Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE.
• Collaborate with R&D across UCC on design and development of current and new products. Perform DFA (Design For Assembly) and DFSS (Design For Six Sigma) analysis and establish assembly requirements and implement process controls to ensure product quality and consistency.
• Guide in design for manufacturability & assembly principles.
• Define manufacturing technology strategy for NPD and product design changes, influence product design through DFMA analysis and enable successful industrialization and transfer to factories.
• Ensure the assembly process is understood to minimize risk. Develop and implement assembly risk mitigation plans.
• Ensure DFMA efforts contribute to achieving COGS/GP targets in the business case.
• Support development of DFMA standards and best practices for the Product Manufacturability and Assembly Design GIE team.
• Identify opportunities for existing manufacturing processes and areas for improvement.
• Design new manufacturing processes that are efficient, within targeted Cap Ex & COGS, and scalable.
• Suggest alternative design iterations exploring form factors, materials, and solutions to address user needs and manufacturing constraints.
• Support process validations to ensure regulatory compliance.
• Collaborate cross-functionally with R&D and manufacturing specialists to ensure designs align with requirements and are optimized for manufacturability, assembly, and performance.
• Act as SME in DFMA, engineering, and process for assembly.
• Review and revise CAD models to ensure accuracy and alignment with specifications, standards, and manufacturing requirements.
• Participate in design verification/testing activities and present data clearly to all levels of the organization.
• Ensure alignment with local, state, federal, and BD safety laws, policies, and procedures, and with BD quality policies and practices through sound quality assurance principles.

• Provide technical leadership in the concept development of design control documentation.
• Develop project plans and execute prioritization and scheduling to meet business goals.
• Lead technical process reviews and ensure components/assemblies are designed for manufacturability/excellence (DFM/DFx).

• Plan, coordinate, and lead all technical activities associated with commercialization and launch of new products.
• Develop manufacturing concepts and processes; coordinate tooling and equipment development; support makes vs buy analyses; assist site selection; coordinate vendor equipment and tooling; develop product and process documentation; develop validation protocols and cost estimates; support capital requisitions; evaluate new materials.

• BS in Mechanical, Biomedical, Chemical Engineering or equivalent with 10 years of experience OR MBA/MS in Engineering with 8 years of experience.
• 5 years of experience in advanced manufacturing engineering, product design, and/or technical leadership in Medical Device or similarly regulated industry OR…