Manufacturing Engineer

KYDA Partners Ltd; Franklin (WI); On-site; USD 80,000 - 105,000; Full time

Job summary

KYDA Partners Ltd in Franklin, Wisconsin is seeking a Manufacturing Engineer to drive hands-on improvements on the floor, solving problems and validating new equipment and processes.

The role collaborates with Manufacturing, Quality, Maintenance and Engineering in a regulated medical-device setting to reduce scrap, improve productivity, and ensure successful process validation across extrusion, molding, assembly and packaging.

Qualifications

• Bachelor's degree in Engineering or related technical discipline; Polymer Science is relevant.
• 3+ years hands-on manufacturing engineering experience.
• Experience in medical devices or other highly regulated manufacturing environments.
• Experience with thermoplastic/thermoset extrusion, molding, assembly and/or packaging.
• 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 CI training is beneficial.
• Comfortable on the manufacturing floor working with operators, technicians, Quality and Operations.

Responsibilities

• 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, Kaizen and Lean 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 to transition new products into manufacturing.
• Train operators and provide technical guidance to process and maintenance technicians.
• Manage manufacturing-engineering projects from problem identification through implementation and validation.

Skills

Hands-on manufacturing engineering

Root-cause analysis

Lean / CI mindset

Six Sigma Green Belt/Black Belt

Operator training & guidance

Education

Bachelor's degree in Engineering

Polymer Science background

Tools

IQ/OQ/PQ

CAPA

FMEA/PFMEA

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

• 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.