Job Description
DOMAIN: Medical
· Combination of Mechanical & Manufacturing, with Medical Devices background.
· Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports.
· Working on sample size determination, creating sample size for Testings, for Design Verification, Validation, Process Validation and Test Method Validation
· Hands on experience working on Validation reports for the Manufacturing site that are moving from once place to another. This includes Facility Validation as well.
· Hands on experience on drafting Protocols, Testings, Data Analysis and Test Reports
· Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution
· Understanding on Software elements would be an added advantage
· Knowledge on IVDR and DHF Remediation also will be an added advantage
· Good understanding on Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation and Risk Management with FMEA working.
· Methods
· Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository
· Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
· Good knowledge in various manufacturing process like Machining, Sheet Metal, Plastics and DFM/A.
· Familiar with Engineering Change Orders and Engineering Change Notes
· Proven track record of problem solving
· Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
· Provide Project status updates to the work group, tracking the overall project implementation.
· Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel
· Methods
· Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository
· Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
· Good knowledge in various manufacturing process like Machining, Sheet Metal, Plastics and DFM/A.
· Familiar with Engineering Change Orders and Engineering Change Notes
· Proven track record of problem solving
· Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
· Provide Project status updates to the work group, tracking the overall project implementation.
· Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel
Experience with QC Tools and Statistical method
· Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository
· Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
· Good knowledge in various manufacturing process like Machining, Sheet Metal, Plastics and DFM/A.
· Familiar with Engineering Change Orders and Engineering Change Notes
· Proven track record of problem solving
· Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
· Provide Project status updates to the work group, tracking the overall project implementation.
· Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel.
Thanks and Regards,
Mohammed Ilyas,
PH - 229-264-4029
Additional Information
All your information will be kept confidential according to EEO guidelines.