This position is responsible for investigating, planning, and implementing 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. Involved with leading projects of varied scope requiring engineering team effort or a multi-discipline team effort. Considered the technical expert in his/her area of engineering. Assigns delegates and assists in providing engineering related duties or projects to lower level engineers, designers, and technicians. Ensures compliance to Terumo s quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization. This 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. Job Details: 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. Provide technical assistance and leadership required to plan and implement projects to develop, install, and qualify new products, and/or new processes for manufacturing new products or for improving existing processes according to business plan objectives. 3. Provide engineering expertise in the design, fabrication, development, installation, validation and qualification of equipment / product which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment. 4. Monitor and control programs, identify issues and ensure they are resolved. 5. Ensure proper documentation is prepared or corrected to reflect any changes implemented. 6. Research and implement cost reduction projects, lines, extensions, and/or products. 7. Provides assistance to production as required. 8. Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders. 9. Assign, delegate and assist in the completion of engineering tasks or projects to lower lever engineers. 10. Responsible for leading projects of varied scope, which include overseeing other department personnel in the implementation of new or modified equipment, products, or processes. 11. May be necessary to coordinate the activities of support groups such as purchasing, scheduling, production, etc. Collecting of data from various sections. 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. Position Requirements: BS in Engineering, Material Science or related field. Advanced degree (MS) is preferred with at least 6 years of increasing responsibility and experience in medical device Manufacturing Engineering, Process Engineering and/or Sustaining Engineering. Experience in a manufacturing environment for designing, specifying, assembling, and validating manufacturing equipment and processes. Experience in catheter manufacturing processes and/or catheter prototyping required. Additional experience in manufacturing processes for other types of medical devices a plus. Excellent analytical and problem solving skills. Thorough knowledge of statistical techniques, DMAIC/six-sigma certification preferred. Experience, training, or certifications in Lean manufacturing techniques a plus. Experience required in experimental design and analysis for process development, characterization, and optimization. Thorough knowledge of FDA process validations, including development of protocols and execution of protocols. Successful experience leading project teams is preferred.