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Identify, investigate, plan and conduct activities to improve and assure quality design and manufacturing of medical devices and components.  Act as liaison between product engineering, production, supply chain and quality with respect to quality improvements, compliance and cost management with an emphasis on the weld processes and procedures.

  • Ensure that design and design changes comply with all specified regulatory agencies. 
  • Develop new fabrication processes and procedures.
  • Improve existing welding equipment, consumables and processes.
  • Coordinate with design teams to optimize designs for manufacturability.
  • Provide technical data and execute decisions that impact compliance with design specifications.
  • Develop, maintain and improve the quality management system to ensure compliance to all specified regulatory agencies.
  • Problem solve to effectively investigate nonconformance using Root Cause Analysis.
  • Participate in Item Qualification/Commercialization activities from protocol development, to testing, to a completed final report.

  • Apply Midmark Production System (MPS) concepts to identify and eliminate non-value added tasks and activities in the various areas of responsibility.
  • Lead and participate in Process Validation activities.
  • Create documents related to engineering function.  Documentation includes detail drawings, assembly drawings, Bill of Materials, Change Orders, product and component test specifications and design records
  • Participate as a member of product research teams to acquire detailed product and user knowledge and lead activities
  • Perform statistical analysis of all design and development data related to quality design. Develop, collect, interpret, develop SPC limits and organize results.

  • Bachelor Degree in Weld or Manufacturing Engineering or related field preferred. At least 1 year of experience in a quality or engineering role or a combination of education and experience.

  • Experience with Enterprise Resource Planning (ERP) systems
  • Experience with Engineering Software systems
  • Experience with Minitab

  • N/A

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