Engineer I, Mfg. Engineering

Job Summary

This position has the responsibility for basic aspects of the products manufactured and/or the equipment at a Terumo Medical Corporation (TMC) facility in terms of performance, safety, reliability, and quality. The work performed involves investigating, planning, and implementing improvements and/or changes to current products and manufacturing processes.  Salary: $62,000 - $93,000 based on experience plus a 5% annual target bonus. 

Job Details/Responsibilities

1.    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.
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.    Plan and implement specified projects centered on various changes that affect current product and/or processes.  This includes organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.
4.    Provide engineering support to the design, fabrication, development, installation, validation and qualification of equipment and/or processes. 
5.    Research and implement cost reduction projects. 
6.    Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required. 
7.    Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement.
8.    May be responsible for projects which include overseeing other departmental personnel in the implementation of new or modified equipment or processes.  
9.    Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.  
10.    Performs other job related duties assigned.

Knowledge, Skills and Abilities (KSA)

• Familiarity with some electronic/chemical equipment and tools in laboratory testing is a plus.
• This position requires the ability to solve basic to moderately complex problems or

    implement solutions or processes that are novel to production processes and engineering

    solutions.

• Incumbent is required to respond to challenging engineering situations and production

          issues.

• Ability to create and work from engineering drawings and/or specs of particular engineering

    discipline.

• Good analytical and problem solving skills. 
• Basic knowledge of statistical techniques/methods is a plus. 
• General knowledge of drafting. 
• Communicating skills both verbal and written. 
• Ability to lead project work.
• Computer knowledge.

Qualifications/ Background Experiences

• Typically requires a four year degree in an engineering discipline such as Mechanical, Electrical, Chemical, Material Science.
• 0 to 3 or more years of experience with manufacturing equipment and/or processes.