Validation Engineer

Job Description

· 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.