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.
George Konik Associates - 18 months ago