Manufacturing Engineer

Job Description

KYDA Partners is supporting a growing medical-device manufacturing organization in Franklin, Wisconsin with the appointment of a Manufacturing Engineer . This is a hands-on engineering position for someone who enjoys being close to the manufacturing floor — solving technical problems, improving processes, reducing scrap and supporting the introduction and validation of manufacturing equipment and processes. The role will work closely with Manufacturing, Quality, Maintenance and Engineering within a regulated medical-device environment.

What you'll be doing

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• Provide day-to-day technical and engineering support to manufacturing operations across extrusion, molding, assembly and packaging processes.
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• Troubleshoot process, material, tooling, mold and equipment issues using structured root-cause analysis.
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• Lead manufacturing improvements focused on scrap reduction, productivity, quality, cost and process capability .
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• Develop and implement practical, cost-effective manufacturing solutions.
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• Lead and support IQ/OQ/PQ process and equipment validation , qualification and revalidation activities.
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• Participate in FMEA, process-flow and design/tooling reviews , as well as Kaizen and Lean improvement initiatives.
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• Support CAPA investigations and implement sustainable corrective actions.
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• Develop and maintain manufacturing procedures, work instructions, troubleshooting guides and engineering-change documentation.
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• Work with Project Engineering and cross-functional teams to transition new products and processes into manufacturing.
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• Train operators and provide technical guidance to process and maintenance technicians.
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• Manage manufacturing-engineering projects from problem identification through implementation and validation.
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What we're looking for

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• Bachelor's degree in Engineering or a related technical discipline ; Polymer Science or a related background would be particularly relevant.
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• Approximately 3+ years of hands-on manufacturing engineering experience .
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• Experience within medical devices or another highly regulated manufacturing environment strongly preferred.
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• Practical experience supporting manufacturing processes such as thermoplastic/thermoset extrusion, molding, assembly and/or packaging would be highly desirable.
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• Experience with IQ/OQ/PQ, process validation, root-cause analysis, CAPA and FMEA/PFMEA .
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• Strong Lean/continuous-improvement mindset with evidence of improving manufacturing performance.
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• Six Sigma Green Belt/Black Belt or similar CI training is beneficial.
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• Comfortable spending significant time on the manufacturing floor and working directly with operators, technicians, Quality and Operations.
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