Mechanical Engineer

4 weeks ago


Memphis, Tennessee, United States Wipro Limited Full time

Nice to have· Create and execute verification and validation plans protocols and reports.· Create or update the risk management file for the product.· Maintain compliance to the standards and policies of the Laborie Management System including organizational adherence to the ISO 13485 and ISO 9001 registration standards.· NOTE Other duties may be assigned.· Working knowledge of medical device design control processes design change and document change control product lifecycles and product verification and validation methodologies· Experience writing test protocols performing tests and writing reports specifically in Verification and Validation· Solid project management experience to drive completion of projects and practical application of a design controlled product development process.

· Experience designing and developing devices with 3D CAD; exposure to 3D printing is a plus· Experience designing fabrication and/or specifying of test fixtures tooling and equipment necessary for development of disposable medical products and processes· Demonstrated understanding or ability to understand Medical Device QMS and regulatory requirements including FDA CFR and ISO 13485 and other applicable standards· Demonstrated knowledge of

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