MDR Manufacturing Engineer - Georgia IT Inc.
North Haven, CT
About the Job
Title: MDR Manufacturing Engineer
Location: North Haven, Connecticut
Duration:12 months; Contract
Rate: DOE
Work Authorization;- USC,GC,TN,GC-EAD,H4EAD only No third party agencies corp to corp
JOB DESCRIPTION
• 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
Required Skillset(s)
• The Quality Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution. Assist with the review and coordination of the Process Validations and provide guidance and resolution of remediation activities.
• 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).
• Excellent organization, Planning, Computer skills, Technical writing, Communication skills. MS Office Suite and Outlook.
• 2 years minimum experience
Nice to have skills:
• 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
Education
BE, Btech undegraduation in Mechanical, Industrial Engineering
Location: North Haven, Connecticut
Duration:12 months; Contract
Rate: DOE
Work Authorization;- USC,GC,TN,GC-EAD,H4EAD only No third party agencies corp to corp
JOB DESCRIPTION
• 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
Required Skillset(s)
• The Quality Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution. Assist with the review and coordination of the Process Validations and provide guidance and resolution of remediation activities.
• 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).
• Excellent organization, Planning, Computer skills, Technical writing, Communication skills. MS Office Suite and Outlook.
• 2 years minimum experience
Nice to have skills:
• 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
Education
BE, Btech undegraduation in Mechanical, Industrial Engineering
Source : Georgia IT Inc.