Hi,

This is Prashant, a Senior Recruiter from Triunity Software, Inc. a leading staffing organization. I came across your profile in one of the job boards and feel that your skills and professional experience would be a good fit for a position with one of our premier clients. Please review the job description below.

If you are interested in this position, please forward your updated resume for immediate consideration and preferred time to discuss this opportunity further.

Title: Validation Engineer

Experience: 4 - 5 years

Location: San Jose, CA, USA onsite

Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Eng. / M.S. Mech. Eng.

Note: Looking for a candidate who worked on Medical Devices OR Companies who Manufactures Medical Devices.

The experience looking for is as follows:

3 years relevant experience in Medical Device Manufacturing.

Clean room environment experience

Experience with Test Method Validation and/or 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, 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 and/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

Follow me on Linkedin: https://www.linkedin.com/in/usaprashantrathore/