R&D Engineer I: Medical Devices & Process Innovation

Terumo-Neuro-1; Aliso Viejo (CA); On-site; USD 63,000 - 83,000; Full time

Job summary

Terumo-Neuro-1 is seeking an engineering professional to support medical devices across development, production, and processes. Responsibilities include creating or verifying specifications, maintaining and enhancing product processes, and designing fixtures and equipment to meet specifications.

Join efforts to evaluate and establish improved engineering and process validation. You will lead prototype builds, train operators, coordinate with planning, and work with quality to develop testing

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; train operators and coordinate 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.
• 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.
• 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 is seeking an engineering professional to support medical devices across development, production, and processes. Responsibilities include creating or verifying specifications, maintaining and enhancing product processes, and designing fixtures and equipment to meet specifications.

Join efforts to evaluate and establish improved engineering and process validation. You will lead prototype builds, train operators, coordinate with planning, and work with quality to develop testing