Manufacturing Process Engineer II

About the role

Terumo Neuro is hiring a Manufacturing Process Engineer II in Aliso Viejo, California, to support the manufacturing of medical device products. The role covers writing or verifying specifications, maintaining product processes, designing fixtures and testing processes, equipment and raw materials so that subassemblies and finished products meet their requirements. It works closely with R&D, Quality and Regulatory to support new products and processes and their transfer to manufacturing and production.

Key responsibilities

• Support new and existing manufacturing processes, new products, product changes and enhancements, and related tooling and fixtures.
• Support validation of product, equipment and processes, draft and execute validations, and manage process validation and product transfer across facilities.
• Manage builds for new product development in prototype and pilot production, including assembler training and coordination with production planning.
• Analyze data and improve processes to ensure robust, repeatable manufacturing.
• Interface with other departments to solve production problems and investigate and test product processes, NCRs, DCs and EO's.
• Monitor the equipment maintenance program and review and develop manufacturing documents such as MP, routers and BOM.

Required profile

• Bachelor of Science in a related field or equivalent experience.
• Minimum of two years of related experience.
• Strong written and verbal communication skills.
• Good problem-solving and conflict-management skills.

Required skills

• Working knowledge of standard machine shop equipment and processes.
• Proficiency in MS Word, Excel and AutoCAD.
• Knowledge of process validations in a medical device manufacturing environment.
• Ability to read and prepare technical documentation.
• Proficiency in SolidWorks and fixture/tooling design.
• Desired: knowledge of DOE and Cpk, and Green Belt or Black Belt certification.