This position will have overall Plant responsibility for Operational Excellence work streams, and will lead the organization’s capability in knowledge and understanding of metrics and measurements which impact the total performance of the organization. This position is responsible for leading the investigation, planning, and implementation of the more complex improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality and productivity with the end result of producing a better quality product more efficiently. As the scope of this initiative is plant-wide, you will collaborate with all functions and departments, at all levels, as well as other sites. The position draws on the entire spectrum of lean and continuous improvement principles and methodologies to provide operational excellence input in the establishment of significant strategic value to the organization. Working with Leadership and cross-functional teams, the position has responsibility for the management and execution of the organization’s operational excellence program, developing and maintaining the resources necessary for executing the operational excellence strategy, the operational excellence training curriculum, and for providing input to managers for their associates' operational excellence development planning. This position will lead the continuous improvement activities of support groups such as purchasing, facilities, scheduling or production. Assigns, delegates, and assists in providing Operational Excellence-related activities or projects to engineers and shop floor associates. Ensures compliance to Terumo’s quality policy, rapid response to shop floor process flow issues, and assist/lead continuous improvement kaizen event activities. The position has the responsibility for all aspects of the products manufactured/designed and equipment used at Terumo in terms of performance, safety, reliability, and quality. The work performed affects the work of section operators, quality assurance, the impression of our product on customers, and the overall cost savings/profits to the Company.
1. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements. 2. Ensure that the Opex methodology is utilized to drive sustainable manufacturing and business process improvements that optimize capacity, reduce lead-time, minimize inventories, maximize fill-rates, process flow, and productivity. 3. Monitor and control programs, identify issues and ensure they are resolved. 4. Initiate, lead and champion lean projects, i.e., Lean Production, Lean Support, with the Production, Process Development, Manufacturing Engineering and support functions, and work with local management to create the Lean Vision for the plant. 5. Lead facility layout and design projects with the Process development, Engineering and the Production, Facilities and Manufacturing Teams. This includes creating designs, updating drawings, process flows, & Value Stream Maps that clarify and/or resolve relevant operational issues. 6. Provide engineering expertise to 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. 7. In conjunction with the Site/functional staff and change management teams, translate these strategic imperatives into specific projects, measures, and timelines that will drive execution 8. Develops an implementation plan, conducts risk assessments and develops contingency plans to accommodate unforeseen events. Recognizes and removes barriers to project completion. Recognizes the broader implications of actions and proposals on the overall business. Support production in the creation of visual staffing plans, lean deployment, and standard work sequencing and production task time adherence. 9. Actively encourage, promote and facilitate implementation of creative solutions to ensure quality while delivering lower costs and shorter lead times. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders. 10. Assign, delegate and assist in the completion of engineering tasks or projects to engineers. 11. Responsible for leading projects of varied scope, which include overseeing the department personnel in the implementation of new or modified equipment, products, or processes. 12. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement. 13. Performs other job related duties assigned.
Qualifications Position Requirements:
BS in Industrial or Process Engineering or related field. Advanced degree (MS) is preferred with at least 10 years of increasing responsibility and experience in medical device Manufacturing Engineering, Industrial Engineering and/or Sustaining Engineering.
Experience in a manufacturing environment for designing, specifying and implementing manufacturing equipment layout for maximum efficiency in process flow; improve and validate manufacturing processes, and /or solve complex engineering problems.
Thinks globally but acts locally, and understands and works to improve effectiveness of the TMC matrix.
Requires 3+ years of management experience
Experience training, or certifications in Lean manufacturing techniques
Knowledge of GMP/FDA regulations.
Ability to create and work from engineering drawings.
Requires strong communications skills to understand and explain complex engineering problems to non-engineering personnel.
Six Sigma experience and certifications along with large-scale automation experience is a plus.
This position requires excellent interpersonal skills, demonstrated ability to effectively lead in a team environment, adaptable to change, able to manage competing priorities, excellent analytical and problem solving skills, excellent written and verbal communication skills and sense of business savvy. Requires the ability to make critical decisions in a fast-paced production environment. Solicits the cooperation of a diverse group of disciplines and functions in a tactful and persuasive manner.