Job Description :
Role: Design Engineer- UDI-DPM
Location: Cincinnati, OH
Duration: Full Time
Salary: $100K-110K+Benefits
Work Authorization (Citizen/GC/H1B/Either)
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