Engineer II, NPI & Transfers

About the role

Terumo Neuro is hiring an Engineer II, NPI & Transfers in Aliso Viejo, California. The role supports medical devices for existing and new product development, production and processes, including creating or verifying specifications, maintaining and improving product processes, and designing fixtures and equipment. It covers new product introduction projects, process development engineering, quality system improvement and engineering validation.

Key responsibilities

• Support new and existing manufacturing processes, new products, product changes and enhancements, and related tooling and fixtures
• Draft and execute validation of product, equipment and processes
• Provide mechanical design concepts for new equipment and fixturing to improve process capability, capacity, efficiency, cost and quality
• Lead builds for new product development in prototype and pilot production, including operator training and coordination with production planning
• Analyze data and improve processes to ensure robust, repeatable manufacturing
• Prepare process modifications, clarify problems and develop processes with other departments and outside services
• Support process validation and product transfer across facilities and product lines
• Develop manufacturing documents such as MP, routers, BOM, drawings and specifications
• Maintain project timelines, milestones and deliverables for the NPI process
• Work with quality to set testing and inspection protocols and with design engineers to optimize designs for manufacturing and assembly
• Review designs for manufacturability and assembly issues and recommend improvements

Required profile

• Bachelor of Science degree in Engineering or a related field
• At least two years of relevant manufacturing process development experience
• Strong written and verbal communication, organizational skills and ability to work in a fast-paced, self-directed environment

Required skills

• Inferential statistical process analysis techniques
• Mechanical design methods using SolidWorks
• MS Word, Excel, Teams and Outlook
• Desired: four years of process development experience, process validation in medical devices, DOE and Cpk, advanced CAD modeling, Six Sigma or Lean