MDR Manufacturing Engineer

Title : MDR Manufacturing Engineer

Location :
North Haven, Connecticut (Day one onsite)

Rate :
Max $50/Hr on C2C

Tata Elxsi | Medtronics

Here is a short summary for the MDR Manufacturing Engineer:

• The Manufacturing Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution. Conduct, coordinate and aid in formal Process Validations including protocol development and execution.
• Working knowledge of manual and automated/semi-automated equipment. The thrust of this assignment is related to pre-printed materials and labeling.
• Collaborate on the project team and work under the direction of the Project Manager in a fast-paced environment supporting program initiatives and compliant with company best practices.
• Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system).
• Generate and revise Bills Of Materials as applied to Versioning.
• Working under the guidance of the Senior and/or Principal Engineer.
• Excellent organization, Planning, Computer skills, Technical writing, Communication skills. MS Office Suite and Outlook.
• 2 years minimum experience

Nice to have

• Working knowledge of medical device manufacturing a plus
• Working knowledge of product packaging and sealing equipment a plus
• Working knowledge of EU MDD (Medical Device Directive) and MDR (Medical Devices Regulation) requirements a plus
• Working knowledge of Unique Device Identifier (UDI) regulations a plus