Manufacturing Engineer-Medical Device
George Konik Associates - Minneapolis, MN

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The Manufacturing Engineer will provide technical support to ensure the following objectives are met:

1. Production lines consistently remain running, customer delivery requirements are fulfilled.

2. All manufacturing equipment is operating efficiently and effectively.

3. Materials for non-conformances are handled appropriately.

4. Manufacturing instructions are clearly documented and understood.

5. Material scrap is minimized.


· Support Manufacturing by identifying and implementing Lean Manufacturing Methodologies.

· Provide technical support for reducing TPCT, Cost, and supporting high Yields and Linearity.

· Develop, implement and maintain department procedur es to assure uniform application of and adherence to engineering practices.

· Perform equipment analysis and create corresponding reporting.

· Coordinate manufacturing process validation activities.

· Train manufacturing personnel on new products and related procedures, new equipment operation and maintenance of equipment.

· Generate maintenance procedures, up-date them as required, and perform designated machinery maintenance activities.

· Review or revise maintenance procedures as required.

· Validate new equipment and/or re-validate any repaired equipment.

· Coordinate the installation and validation of new or repaired equipment.

· Communicate with Quality Assurance personnel regarding validation dates and obtain approval of validation efforts.

· Analyze manufacturing operations and equipment and advise management of any machinery that may enhance company production quality and/or efficiency.

· Provide technical support for all manufacturing functions as needed.


· 4-year degree in Manufacturing Engineering or 2-year Technical Engineering Degree.

· 3+ years working in a medical device-manufacturing environment with understanding of ISO 13485 and FDA regulations.

· Experience with production work cell designs, product packaging, sterile packaging or contract manufacturing services.

· Strong working knowledge of Lean Manufacturing methodologies.

· Intermediate to advanced skills in Microsoft Office.

· Hands-on experience with Statistical Analysis software preferred.

Haley Behrens



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