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Design Engineer
Ref No.: 18-40103
Location: Cincinnati, Ohio
Position Type:Direct Placement
Start Date: 06/11/2018
  • Extensive experience in Unique Device Identifier (UDI) and Direct Part Marking (UDI-DPM) for the Class 1 medical devices machined components
  • Experience in understanding Class 1 machined component drawings, working with marketing and manufacturing team to understand how it's used and on how it can be marked physically
  • Experience in feasibility study of existing markings on parts, determine feasibility of adding UDI markings on parts
  • Experience in different types of part marking methods and implementations like engrave, laser marking etc.
  • Experience in new label creation and release in compliance with UDI and well versed with UDI compliance and FDA regulations.
  • Coordinating and scheduling meetings with the Suppliers, R&D, Quality and Sourcing teams to implement UDI markings and analyze costs of production
  • Support Engineering change process via Engineering Change request(ECR) Engineering Change Order (ECO)
  • Knowledge in labelling standards EN 1041, EN980, ISO 15223-1, etc.,
  • Experienced and proficient with CAD tools such as Solid works, AutoCAD and Knowledge on PLM tool AGILE preferable.
  • Ability to interact directly with the customer, provide support and critical thinking to cross-functional teams
  • Excellent written and verbal communication skills