Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary:

The Senior Engineer 1 - Manufacturing Engineer position is responsible for ensuring the successful day-to-day operation and continuous improvement of a dedicated endovascular medical device manufacturing process within the Terumo Medical Corporation (TMC) Elkton, MD facility. In this role, the manufacturing engineer serves as the subject matter expert (SME) for the manufacturing process they are assigned to.

Job Details:

• Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned production process and related business continuity needs. Troubleshoot manufacturing process and equipment.
• Work with Quality Engineering and Production personnel in the conduct of root cause analyses of process non-conformances and implementation of corrective actions.
• Provide manufacturing engineering leadership and expertise to the identification, execution and implementation of performance and cost reduction continuous improvement opportunities of assigned production process. Utilize tools such Gage R&R, Cp, Cpk, and SPC to improve processes. Implement manufacturing concepts like Value Stream mapping, 5S and lean manufacturing and Visual Workplace to improve quality, labor efficiency, and throughput.
• Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment / product to ensure proper operation of the equipment.
• Provide assistance to production as required.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
• Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other job related duties assigned.

• Knowledge, Skills and Abilities (KSAs)

• Demonstrated ability to design, specify, assemble and validate manufacturing equipment and processes.

• Demonstrated application of Lean Six Sigma principles and tools. Black belt certification is desirable.
• Demonstrated ability in the use of critical thinking, problem solving and analysis.
• Demonstrated ability in the use of statistical experimental design and analysis techniques. Working knowledge of Statistical Process Control (SPC), Six Sigma principals and tools and Kepner-Tregoe problem solving and decision-making tools.
• Effective communication skills, both verbal and written.

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  Background Experiences
  • BS in Engineering or other related technical field.
  • Career progression of 6 or more years of experience with manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.