At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.
This position is responsible for strategic planning, setting direction, and oversight for improvements to the manufacturing processes of existing products or development of new products. These projects directly affect safety, quality, and productivity with the end result of producing a better quality product more efficiently.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Participate in the development of Company goals and develop the strategies for Manufacturing Engineering, Operations, and/or Product Development departments as applicable by site. 3. Lead Six Sigma and Statistical Experimental design activities to improve manufacturing processes and increase efficiencies. 4. Manage and lead project teams for the implementation of product improvements into manufacturing. Recognize and identify challenges that pose a threat to the completion of programs and formulate plans for course correction. Communicate with all departments regarding the project status as needed. Ensure that projects are completed on time and on budget. Participate in other projects teams as necessary. 5. Manage and administer design controls, maintenance, and calibrations for the facility. 6. Interact with other departments within the company and the contract manufacturers and suppliers on a regular basis to ensure that new products, processes, and plans are incorporated into departmental activities as required. 7. Manage and resolve any issues to the manufacturing process on an on-going basis. This includes managing all engineering efforts as they relate to current production. Provide leadership and guidance for process, product, and process software validation activities. 8. Develop and implement plans for product/prototype transition to manufacturing. Develop budgetary evaluations on manufacturing costs to be used in project/product feasibility. 9. Take an active role in cultivating continuous improvement culture within the Engineering group. 10. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs. 11. Perform other duties as assigned.
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