Job Summary: This position is responsible for investigating, planning, and implementing the more complex improvements and/or additions to current and new product manufacturing processes. The end result of this process is to produce a quality product, safely and efficiently. This position has the responsibility for all aspects of the products manufactured and equipment at Terumo in terms of performance, safety, reliability, and quality. The work performed effects the work of section operators, quality assurance, the impression of our product on customers, and the overall cost savings to the Company. Frequent cross-departmental interface and external interface with vendors and suppliers. No direct reports, however, may be responsible for projects which include overseeing other departmental personnel in the implementation of new or modified equipment or processes. Coordinate the activities of support groups such as purchasing, scheduling or production and collecting data from various sections. Job Details: 1. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, document/data control, change control practices. 2. Provide engineering support for the manufacture of medical devices. 3. Identify and lead value improvement and waste elimination projects for the manufacturing and overhead areas that drive plant and company performance improvements while championing the development and advancement of the lean culture within the organization. 4. Initiate, lead and champion lean projects, ie, Lean Production, Lean Support, with the Production, Process Development, Manufacturing Engineering and support functions. 5. Lead facility layout and design projects with the Process development Engineering and the Production, Facilities and Manufacturing Teams. 6. Drive the ongoing introduction and advancement of lean manufacturing culture, principles and practices across the plant; work with local management to create the Lean Vision for the plant. 7. Assist production with determination of causes for chronic and sporadic downtime associated productivity losses. 8. Conduct cycle time studies and motion studies to establish process standards and support process / efficiency improvements. 9. Support production in the creation of visual staffing plans, lean deployment, and standard work sequencing and production takt time adherence. 10. Perform general engineering tasks, which may include: creating and updating standards, maintaining BOMS and routers and creating and approving change orders. 11. Conduct ergonomic reviews; assist with ergonomic improvements. 12. Develop and conduct Lean training programs for employees at all levels and departments. 13. Create, maintain and refine a lean toolkit which includes: 5S, Kaizan, quick change over, value stream mapping, mistake proofing and line balancing. 14. Promote cross-functional and inter-site teamwork to accomplish shared objectives. 15. May supervise, mentor or provide work direction to other members of the Industrial Engineering team. 16. Follow requirements of applicable national and international regulations 17. Perform other job related duties as required. Position Requirements: Knowledge, Skills and Abilities (KSAs) * This position requires the ability to solve complex engineering problems or implement solutions or processes for manufacturing. * Requires a detailed knowledge of the entire product line, manufacturing processes and a thorough understanding of manufacturing engineering principles and practices. * Ability to plan and implement specified projects to be completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.; Background Experiences * Typically requires a Bachelor s degree in Industrial Engineering, Mechanical Engineering or a related engineering field. * Requires a minimum of 3 years experience in a similar job or as an Industrial Engineer, Mechanical Engineer or Process Engineer in a related engineering work environment. * Must have experience working in a lean manufacturing environment and demonstrate ability to manage complex projects and multiple priorities.