Manufacturing Process Engineer I – Medical Devices

Terumo Neuro; Aliso Viejo (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Terumo Neuro is seeking an Engineer I, Manufacturing Process to support the development and transfer of medical device manufacturing processes. You will work closely with R&D, Quality, and Regulatory to ensure successful product transfers and scalable production.

The role involves drafting validations, improving processes, and coordinating with planning and operators in prototype and pilot environments. Strong CAD/SolidWorks and documentation skills are essential.

Qualifications

• Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.).
• Strong written and verbal communication skills.
• Computer skills including Word, Excel, and PowerPoint.
• Proficiency in SolidWorks (and/or CAD) and fixture/tooling design.
• Ability to read and prepare technical documentation.
• Working knowledge of standard machine shop equipment and process.

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.

Skills

Communication

MS Office

SolidWorks

CAD

Technical docs

Machining basics

Education

Bachelor of Science in engineering or related field

Tools

Fixture design

CAD

Job description

Terumo Neuro is seeking an Engineer I, Manufacturing Process to support the development and transfer of medical device manufacturing processes. You will work closely with R&D, Quality, and Regulatory to ensure successful product transfers and scalable production.

The role involves drafting validations, improving processes, and coordinating with planning and operators in prototype and pilot environments. Strong CAD/SolidWorks and documentation skills are essential.