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Extrusion Engineer
2 months ago
Cretex Medical Component and Device Technologies is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly.
Job SummaryThe Extrusion Engineer will be responsible for leading the development and manufacturing of extruded medical tubing. Initially, the successful candidate must be able to specify equipment and facility needs, work with equipment manufacturers and material suppliers to implement a foundation for Cretex Medical's extrusion business. As equipment is installed, the Extrusion Engineer will work directly with cross-functional teams to identify insourcing opportunities as well as work with customers to develop new opportunities that would support the company's foray into catheter manufacturing.
Key Responsibilities- Specify equipment and facility needs for Cretex Medical's extruded tubing technologies.
- Perform necessary acceptance activities for new equipment, ensuring it is capable of meeting performance requirements and subsequently capable of production quality output.
- Primary technical owner for new extrusion opportunities from R&D phase through NPI and into sustained production.
- Design and develop repeatable manufacturing processes for high-precision polymer extrusions.
- Independently troubleshoot process, equipment, and material challenges.
- Support adjacent technologies or capabilities in catheter assembly as necessary, such as braiding, coil winding, polymer reflow, catheter tipping, and such.
- Identify and hire personnel to support and scale the business and meet customer demand.
- Initiate and complete technical activities leading to new or improved processes or design for manufacturability for current and next-generation programs and to meet strategic goals and objectives of the company.
- Interface with quality and manufacturing to integrate new products or processes into the existing production area.
- Maintain and approve manufacturing routers and bill of materials.
- Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.
- Design, coordinate fabrication, and implementation of extrusion dies, process fixtures, or gauges.
- Bachelor's degree in Mechanical, Industrial, or other Engineering Science or some level of post-secondary technical education with at least 5 years of direct experience in polymer extrusion.
- Experience in an ISO 13485/GMP environment.
- Engineering experience with medical devices.
- Experienced with resin and extrusion management (e.g., handling, storage, moisture management, heat history).
- Manufacturing process design, validation, equipment, and fixture/gauge design.
- Lean manufacturing experience.
- Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict).
- DOE, SPC, FMEA, GMP, QSR.
- Knowledge of statistical software.
- Project management experience.
- Manufacturing automation, including electronic visual inspection.
- 3D CAD software (i.e., ProE, Unigraphics, Solidworks, etc.).
- Continuing Education; including participation in local chapters, associations, and/or organizations.
