Sr. Engineer I, Manufacturing Engineer

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in medical devices is seeking a Senior Engineer 1 - Manufacturing Engineer to oversee manufacturing processes in Elkton, MD. This role requires expertise in engineering and operational improvements while complying with regulations and quality standards. Ideal candidates will have a background in Lean Six Sigma and a strong track record of enhancing productivity in controlled environments.

Qualifications

• 6 or more years of experience in manufacturing for Medical Devices.
• Experience with global regulatory and quality standards.
• Black belt certification in Lean Six Sigma is desirable.

Responsibilities

• Ensure daily operation and continuous improvement of manufacturing processes.
• Troubleshoot equipment and process issues as they arise.
• Lead initiatives for performance improvement and cost reduction.

Skills

Lean Six Sigma principles

Critical thinking

Problem solving

Statistical Process Control (SPC)

Effective communication

Education

BS in Engineering

Job description

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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.

• 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.

Working Conditions/Physical Requirements

• This position will be located in the Terumo facility located in Elkton, MD.
• The position will perform required duties in a controlled-access manufacturing environment.

Knowledge, Skills and Abilities (KSA)

• 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.

Qualifications/ 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.