Process Development Engineer

The Process Development Engineer will function in a hands-on engineering capacity, working with Production, R&D and QA to coordinate all activities associated with the development of products and development or improvement of production processes required for transfer of products from R&D to pilot manufacturing, and from pilot manufacturing to external manufacturing in accordance with the company's Quality Systems and customer contracts.

Additional responsibilities include: verification and validation, creating protocols and procedures, support of the CAPA Program, training assemblers.

To qualify for this position you must possess:

* BS in Engineering or related discipline or equivalent experience
* Min 4 years medical device (preferred) or biotech experience
* Validations experience (IQ, OQ, PQ)
* Solid working knowledge of statistics
* Strong working knowledge of SolidWorks
* Strong working knowledge of FDA QSR and ISO 13485
* Strong understanding of Design Control and Product Development Processes
* Good communication skills and the ability to work individually and in a group setting
* Class II or Class I medical device experience
To find out more about Real please visit www.realstaffing.com