V & V / MDR Validation Engineer

V & V / MDR Validation Engineer

Vacancy expired!

Job Title: V & V / MDR Validation Engineer

Location: Irvine, California

Job Type: 12+ Months Contract

Job Description:

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.

Thanks & Regards,

Mukesh kumar

IT Recruiter, Tanisha Systems Inc
Phone: Ext-364
Email:
LinkedIn: https://www.linkedin.com/in/mukesh-maurya-a040a6147/
Address: 99 Wood Ave South, Suite # 308, Iselin, NJ 08830