Engineer II, Mfg. Engineering

Job Summary

The Engineer II - 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 a technical expert for the manufacturing process they are assigned to.  Involved with leading small to medium size projects requiring engineering resources or a multi-discipline team effort.    

Job Details/Responsibilities

1.    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.
2.    Work with Quality Engineering and Production personnel in the conduct of root cause analyses of process non-conformances and implementation of corrective actions. 
3.    Research and implement cost reduction projects. 
4.    Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment / product to ensure proper operation of the equipment.
5.    Provide assistance to production as required.
6.    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.
7.    Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement.
8.    Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.  
9.    Lead small to medium size cost reduction projects, lines, extensions, and/or products which includes overseeing other department personnel during the project.
10.    Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders.
11.    Performs other job related duties assigned.
 

Benefits/Compensation

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.  Compensation is $73,000 - $109,400.

Knowledge, Skills and Abilities (KSA)

• Demonstrated ability to design, specify, assemble and validate manufacturing equipment and processes varying from simple to medium complexity.

• Demonstrated ability in the use of critical thinking, problem solving and analysis.
• Understanding of the use of statistical experimental design and analysis techniques, Statistical Process Control (SPC), Six Sigma principals and tools and 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 3 or more years of experience with manufacturing equipment and/or processes.
  • Experience with manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements a plus.