Medical Device Process Engineer II – NPI & Validation

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/Process Engineer to support existing and new medical device development, production, and processes. You will create specifications, validate processes, and design fixtures to ensure concepts meet requirements.

Lead builds for prototype and pilot production, analyze data to improve process capability, and collaborate with design, QA, and operations to ensure manufacturability, efficiency, and compliant documentation.

Responsibilities

• Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures
• Draft and execute validation of product, equipment, and processes
• Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality
• Lead builds for new product development in prototype and pilot production settings, including training of operators 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
• Support projects related to process validation and product transfer activities across different manufacturing facilities and product lines
• Develop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.)
• Develop and maintain project timelines, milestones, and deliverables to ensure smooth execution of the NPI process
• Collaborate with the quality team to establish testing and inspection protocols to ensure the final product meets quality standards
• Collaborate with design engineers to optimize product designs for efficient manufacturing and assembly processes
• Review product designs to identify potential manufacturability and assembly issues, providing recommendations for improvements
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
• Perform additional duties as assigned

Job description

Terumo-Neuro-1 in Aliso Viejo, CA is seeking a Manufacturing/Process Engineer to support existing and new medical device development, production, and processes. You will create specifications, validate processes, and design fixtures to ensure concepts meet requirements.

Lead builds for prototype and pilot production, analyze data to improve process capability, and collaborate with design, QA, and operations to ensure manufacturability, efficiency, and compliant documentation.