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.
Job Details/Responsibilities
- 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.
- Work with Quality Engineering and Production personnel in the conduct of root cause analyses of process non-conformances and implementation of corrective actions.
- 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.
- Provide engineering support to the design, fabrication, development, installation, validation and qualification of equipment and/or processes.
- Research and implement cost reduction projects.
- Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required.
- Participate in project team meetings in order to provide ideas, methods, or processes for performance improvement.
- May be responsible for projects which include overseeing other departmental personnel in the implementation of new or modified equipment or processes.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- 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.