Product and Process Design Staff Engineer

Requirements:

• B.S.: 10 years of experience in advanced manufacturing engineering, product design, and/or technical leadership level in Medical Device or other highly regulated industries.
• M.S.: 8 years of experience in advanced manufacturing engineering, product design, and/or technical leadership level in Medical Device or other highly regulated industries.
• Experience with CAD and solid works and design for manufacturing (DFM) and as assembly tolerance requirement(ATR) analysis

Job Description:

The Product & Process Design Staff Engineer will define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for manufacturing and assembly (DFMA) analysis and enable successful industrialization (internal or external) and transfer to specific Business Unit factories. Responsible to work with R&D & Engineering across the a specific Business Unit on the product design and assembly development for current and new products including proof of concept (POC) and feasibility testing support.

• Perform DFMA (Design For Manufacturing and Assembly), DFSS (Design For Six Sigma) analysis, and CAD-based Assembly Tolerance Requirement (ATR) analysis. Establish assembly requirements KPIVs and KPOVs to ensure product quality, cost and cycle time and implement process controls to ensure product quality and consistency.
• Create the process/training for effective DFMA reviews and phase gates. Develop and execute assembly risk mitigation plans and pFMEA analysis.
• Set assembly development standards and practices for the Product and Process Design team. Guide and mentor Product and Process Design team.
• Capture the opportunities for existing assembly processes and identify areas for improvement and inclusion into future DFMA.
• Design new assembly processes that are efficient, within the targeted OEE, CapEx & COGS, and scalable for Vertical Start Up.
• Provide intellectual property for technical assembly solutions and product designs for assembly to secure competitive advantage to the business.
• Subject matter expert in DFMA, engineering, and process for assembly.
• Review and revise detailed CAD models of product designs, ensuring accuracy/adherence to specifications, standards, manufacturing requirements