Engineer II, Manufacturing Process

Terumo-Neuro-1; Aliso Viejo (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Terumo-Neuro-1 in Aliso Viejo, CA is seeking a manufacturing support engineer to help write or verify specifications, maintain processes, design fixtures, and test processes, equipment, and materials to ensure subassemblies and finished products meet requirements.

You will collaborate with R&D, Quality, and Regulatory to transfer products to Manufacturing Engineering for launch, support validation, and manage builds for new product development in prototype and pilot settings.

Responsibilities

• Support new and existing manufacturing processes, product changes, and related tooling.
• Support validation of product, equipment, and processes.
• Interface with other departments to solve production problems.
• Monitor equipment maintenance program.
• Investigate and test product processes, NCR’s, DC’s and EO’s.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype/pilot production, incl. training Assemblers and coordinating with planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.).
• Perform additional duties as assigned.

Job description

Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure that the subassemblies and finished products meet their requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties:

• Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Support validation of product, equipment, and processes.
• Interface with other departments to solve production problems.
• Monitor equipment maintenance program.
• Investigate and test product processes, NCR’s, DC’s and EO’s.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of Assemblers and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.).
• Perform additional duties as assigned.

Job ID 14920BR

Salary Range:

$79,733 - $99,667 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)