Experience Requirements
5-10 years experience in precision extrusion. Experience in using lean, six sigma tools.
Qualification Requirements
Requires BSME; prefer Plastics Engineering Degree. Masters in Plastics Engineering a plus.
Preferred Qualifications
Green / Black Belt desired.
Responsibilities
This hands-on Engineering position will provide TFX Medical with technical support and operating knowledge for our medical extrusion operation. This person will take the lead role in extrusion engineering functions such as validating and troubleshooting processes, identifying and implementing process improvements. The engineer will work with cross-functional teams to move pilot operations into production. The engineer will also be required to work with internal and external machine shops to design and specify tooling/fixturing.
Principle Responsibilities
Troubleshoot and validate extrusion processes (melt extrusion, expansion)
Responsible for strategic planning for extrusion area(s).
Drive C.I.P. activity.
Create and update SOPs
Troubleshoot technical problems related to the production of plastic parts.
Participate in CAPA projects.
Contribute to cross-functional teams that enhance improvement initiatives, capital planning, project implementation, process improvement, and product development.
Initiate, direct and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability.
Perform other related duties as required.
Job Specifications
Knowledge/Skills
Experience in process validations, statistics and SPC using Minitab software...
Knowledge in plastic processing tooling and materials. Experienced in FEP extrusion and FEP Heat Shrink.
Ability to write and perform IQ’s, OQ’s and PQ’s. Experience in transferring product from pilot to production.
Determine root cause of process problems and implement creative solutions.
Use 3D Modeling, preferably SolidWorks
Proficient in designing, acquiring, and implementing new equipment and processes.
Good working knowledge of manufacturing methods, including RF plastic forming, injection molding, and assembly methods
Knowledge in plastics processing, tooling and materials.
Experience with lean manufacturing
Proficient in MS Office Products
Experienced in process controls
Excellent oral and written communication skills
Ability to prioritize and work independently
Familiar with the design controls, FDA regulation, and GMP practices
Experience with risk analyst
Relies heavily on experience and judgment to plan and accomplish goals
Good working knowledge of GD&T.
Ability to prioritize and work independently.
