Manufacturing Engineer

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.

• 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.

• 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 with in 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.