Design Engineer

SUMMARYUnder routine supervision, primarily responsible for the development of customer requested enhancements of existing products. Involved in creating designs, modeling and drafting utilizing a Solid Works. Other responsibilities include assisting in the development processes for Manufacturing, establishing inspection criterion for Quality Control, and creation of Regulatory documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES

* Designs, develops and processes implants and instruments utilizing Solidworks CAD software.
* Assists in the development of new products and manufacturing processes and/or serves as a member of a project team.
* Assists in the development of working prototype models to be used for project design evaluation.
* Generate protocols for testing and analyzing new and current products.
* Generate design assurance documentation for the project Design History File (DHF).
* Develop quality control procedures and inspection methods
* Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
* Serves on cross-functional product development teams responsible for new product development from concept through product launch.
* Provides technical input to marketing counterparts on the development of collateral marketing materials
* Provide technical expertise to marketing and sales as to intent of design function.
* Provide technical experience to Regulatory Affairs to support FDA 510K submissions.
* Creates and processes Engineering Change Orders (ECO's)
* Other duties as assigned.
QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Experience with 3D CAD system, preferably Solidworks
* Experience with phase gate design control processes
* Demonstrated success in product development from concept through product launch
* Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
* Knowledge in the use and interpretation of geometric dimensioning and tolerancing
* Strong verbal and written communication skills; comfortable presenting to senior management
EDUCATION and/or EXPERIENCE· Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics· 1-4 years of product development experience in implantable orthopedic medical devices, preferably in spine.To find out more about Real Staffing please visit www.realstaffing.com