Job Description :
V & V / MDR Validation Engineer (Lead Engineer) Irvine, California 6+ Months Key Skills: 1. Packaging Verification and validations 2. Process Validations 3. Sustenance Activities 4. EU MDR Standards 5. Drawing Redlines JD: Degree in Mechanical, Materials or Biomedical Engineering Design Change Impact and Assessment, Test Protocols and Reports for Medical Products (Catheters, Guidewires etc Aware of ISO11607-1 and 2, ISO15223 and Packaging testings (Seal Strength, Seal Width, Bubble Leak, Aseptic presentation etc Process validations includes Operational Qualification and Performance Qualification (OQ and PQ) Sustenance activities includes Specification & Conformance Matrix (SCM / PS), Design History File (DHF), Risk Management Work Book (RMW), Router Form, Master Validation Matrix Documents (PMVM), BOM, Manufacturing Process (MP) Documents and Drawing Redline updates Discontinuation of products, which includes obsolescence of related documents and drawings. Test Methods sustenance activity and Test Method validation using Minitab Analysis and looking for field work in R&D Labs. Experience on MS Word & Excel knowledge is Must. Interactions with Customer on Workloads, forecast, clarifications and status of Activities handled. Mandatory Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Medical Device Packaging Design Change Assessment, Verifications and validations Good Hands On experience Test Method validation Good Hands On experience Process validations Good Hands On experience
             

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