Job Summary: This position is responsible for investigating, planning, and implementing improvements in manufacturing processes that directly affect safety, quality, and productivity with the end result of producing a better quality product more efficiently, leading to improvement in yields and reduction in cost. May at times be involved with leading projects requiring engineering team effort and/or a multi-discipline team effort. Serve as the technical expert in his/her area(s) of engineering inside and outside the
company. This position is responsible for investigating, planning, and implementing improvements in manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently, leading to improvement in yields and reduction in cost. Job Details: 1. Troubleshoot and improve production processes, investigate and implement alternate processes to improve yield, reduce cost, etc.,
using systematic problem-solving and valid statistical methods (DMAIC/six-sigma certification preferred). Provide technical expertise and leadership in the planning and implementation of projects to improve and/or revalidate existing manufacturing processes. 2. Investigate and qualify material changes to replace obsolete materials for current products as needed to assure production continuity. 3. Recommend, investigate and implement manufacturing cost reduction projects. 4. 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. 5. Monitor and control production processes, identify issues and ensure they are resolved in a timely manner. 6. Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies). 7. Serve as the technical expert in his/her area(s) of engineering inside and outside
the company. 8. Attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders. 9. Ensure compliance to Terumo’s quality policy. 10. Follow all requirements of applicable national and international regulations. 11. May include management of cross-functional teams. 12. Perform other job related duties assigned.
Position Requirements: Knowledge, Skills and Abilities o Experience in a manufacturing environment for designing, specifying, assembling, and validating manufacturing equipment and processes. o Experience in catheter manufacturing processes and/or catheter prototyping required. Additional experience in manufacturing processes for other types of medical devices a plus. o Excellent analytical and problem solving skills. o Thorough knowledge of statistical techniques, DMAIC/six-sigma certification preferred. o Experience, training, or certifications in Lean manufacturing techniques a plus. o Experience required in experimental design and analysis for process development, characterization, and optimization. o Thorough knowledge of FDA process validations, including development of protocols and execution of protocols. o Successful experience leading project
teams is preferred. o Thorough knowledge of equipment and tools in laboratory testing and inspection systems. o Knowledge of GMP/FDA regulations. o Ability to create and work from engineering drawings. o Excellent communication skills both verbal and written. o This position requires the ability to improve and validate manufacturing processes, and/or solve complex engineering problems. o Requires a detailed knowledge of GMP and FDA regulations. o Requires strong communications skills to understand
and explain complex engineering problems to non-engineering personnel. Background Experience o BS in Engineering, Material Science or related field. Advanced degree (MS) is preferred with at least 3 years of increasing responsibility and experience. o 5 years experience in medical device Manufacturing Engineering, Process Engineering and/or Sustaining Engineering is a plus.