Engineer I, Manufacturing Process

Terumo Neuro; Aliso Viejo (CA); On-site; USD 75,000 - 87,000; Full time

Job summary

Terumo Neuro in California seeks a role to support manufacturing process development and the production of medical device products. Responsibilities include writing or verifying specifications, maintaining processes, designing fixtures, and testing processes, equipment, and materials to meet requirements.

You will work with R&D, Quality, and Regulatory to transfer new products and processes to Manufacturing Engineering and Production for launch, including process validation, pilot builds, and

Qualifications

• Support development and validation of manufacturing processes.
• Collaborate with R&D, Quality, Regulatory for new products.
• Translate processes into manufacturing transfer for launch.

Responsibilities

• Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing 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.
• Investigation and testing of product processes.
• Support prototype and pilot production, facilities, and planning when appropriate.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (MP, Routers, BOM, etc.).
• Perform additional duties and responsibilities as assigned.

Job description

Support manufacturing process development and 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 the concepts, sub-assemblies, finished products, and/or prototypes meet 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:

• Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing 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.
• Investigation and testing of product processes.
• Support prototype and pilot production, facilities, and planning when appropriate.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (MP, Routers, BOM, etc.).
• Perform additional duties and responsibilities as assigned.

Job ID 14202BR

Salary Range:

$75,075 - $87,356 (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)