- Responsible for the design, modeling, development and testing of a machine, structure or system. Develops functional requirements.
- Understands and applies standard engineering principles.
- Creates simulations and prototypes to evaluate preliminary designs and test how a machine, structure or system operates.
- Designs and tests components, and integrates components to produce final product.
- Monitors quality of products and controls the efficiency of processes.
- Evaluates a design's overall effectiveness, cost, reliability, and safety.
- Investigates root causes of failures to maintain quality and recommend improvements.
- Demonstrate a primary commitment to patient safety, product quality and compliance with the Company's Quality Manual and its governing regulations.
- Ensure effective Engineering support to Extrusion production department, including troubleshooting process problems and implementation of corrective actions.
- Ensure Engineering commitments to Operations metrics are met (including reporting of Engineering metrics).
- Lead improvement efforts related to the stability and capability of extruded component or sub-assembly manufacturing,
- Proficient in material selection (polymers, fillers, marking additives and colorants) as well as tooling design.
- Independently lead process verification and validation activities for the production of extruded components or sub-assemblies.
- Proficient in use of statistical analysis and methods.
- Partner with R&D in the selection of material and design of new components.
- Perform engineering work related to design, procurement, fabrication, installation, documentation and qualification of manufacturing equipment, tooling and fixtures.
- Train, mentor, and provide direction to operators, technicians, and engineers.
- Ability to effectively communicate with all levels of management, customers, and external regulatory officials.
- * (Preferred) Experience in transferring and qualifying extrusion production equipment from one site to another.
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