Engineer I, R&D
Role Overview
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.
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.
Key Skills for This Role
Full Job Posting
Position Overview
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.
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.
Qualifications
- Bachelor of Science degree in Engineering or a related field.
- Zero (0) to two (2) years of relevant manufacturing process development experience.
- Demonstrated expertise with inferential statistical process analysis techniques.
- Demonstrated expertise with mechanical design methods using SolidWorks.
- Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.
- Proficient with MS Word, Excel, Teams, and Outlook.
- A minimum of one (1) year of relevant manufacturing process development experience.
- Experience in Process Validations in medical device manufacturing environment.
- Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization.
- Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings.
- Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling.
- Experience with Six Sigma or Lean methodologies is advantageous.
- Extended periods of computer use.
- Extended periods of sitting or standing.
- Extended periods working in a cleanroom environment.
- Moderate lifting, up to 50 lbs.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
About Terumo Neuro
Neurovascular medical device innovation and manufacturing.
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