This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. The role involves production support and process validation, troubleshooting manufacturing processes and equipment, and utilizing tools like Gage R&R, Cp, Cpk, and SPC to improve processes. It also requires understanding manufacturing concepts such as Value Stream mapping, 5S, and Visual Workplace to enhance quality, labor efficiency, and throughput. The position involves protocol and report writing, generating and modifying manufacturing process documentation, and working with cross-functional teams. Evaluation of production equipment, development and implementation of process improvements, and interfacing with vendors for incoming components are also key responsibilities. The role supports all Company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, ensuring compliance with FDA regulations and other applicable standards. Maintaining positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors is essential. This position is located in Woodridge – St Paul, MN, within the Structural Heart Business Mission.
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Job Type
Full-time
Career Level
Mid Level