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KYDA Partners Ltd

Manufacturing Engineer

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Job Description

Manufacturing Engineer at KYDA Partners Ltd Manufacturing Engineer at KYDA Partners Ltd in Greendale, Wisconsin Posted in about 19 hours ago.

Type:

full-time 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 Provide day-to-day technical and engineering support to manufacturing operations across extrusion, molding, assembly and packaging processes. Troubleshoot process, material, tooling, mold and equipment issues using structured root-cause analysis. Lead manufacturing improvements focused on scrap reduction, productivity, quality, cost and process capability . Develop and implement practical, cost-effective manufacturing solutions. Lead and support

IQ/OQ/PQ

process and equipment validation , qualification and revalidation activities. Participate in FMEA, process-flow and design/tooling reviews , as well as Kaizen and Lean improvement initiatives. Support CAPA investigations and implement sustainable corrective actions. Develop and maintain manufacturing procedures, work instructions, troubleshooting guides and engineering-change documentation. Work with Project Engineering and cross-functional teams to transition new products and processes into manufacturing. Train operators and provide technical guidance to process and maintenance technicians. Manage manufacturing-engineering projects from problem identification through implementation and validation. What we're looking for Bachelor's degree in Engineering or a related technical discipline ; Polymer Science or a related background would be particularly relevant. Approximately 3+ years of hands-on manufacturing engineering experience . Experience within medical devices or another highly regulated manufacturing environment strongly preferred. Practical experience supporting manufacturing processes such as thermoplastic/thermoset extrusion, molding, assembly and/or packaging would be highly desirable. Experience with IQ/OQ/PQ, process validation, root-cause analysis, CAPA and

FMEA/PFMEA

. Strong Lean/continuous-improvement mindset with evidence of improving manufacturing performance. Six Sigma Green Belt/Black Belt or similar CI training is beneficial. Comfortable spending significant time on the manufacturing floor and working directly with operators, technicians, Quality and Operations.