Validationn Engineer

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 Solid Works.
• 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.