Validationn Engineer

Title: Validation Engineer
Experience: 4 - 5 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.
The experience I am looking for is as follows:
• 3 years relevant experience in Medical Device Manufacturing.
• Clean room environment experience
• Experience with Test Method Validation and Measurement System Analysis is preferred.
• Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
• Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Strong organizational skills, detail-oriented.
• Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint.
• Experience with 3D CAD Software SolidWorks
• Experience working with Engineering change management software & releasing engineering change orders.
Job duties:
• Process and equipment qualification (IQ/OQ/PQ).
• Development of test methods for Design V&V, Process Validation, and Production
• Validation of test methods
• Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
• Authoring/releasing of new test methods and editing/redlining of old test methods
• Experience working in a regulated or medical device environment
• To define equipment requirements
• To draft equipment specifications
• To work on change management and releasing engineering change orders
• To design process validations and identify critical process parameters related to equipment Working