Elite Technical is looking for an innovative new product development engineer for one of our rapidly growing medical device clients.

This individual will be responsible for the design and development planning of new design of products and processes and the change of existing products and processes, including design verification, validation and clinical evaluation.


Responsibilities and Essential Functions:
- Document design inputs to addresses the intended use of the product.
- Design new products and changes.
- Follow procedures for design changes and new products.
- Evaluate the conformance of new products and changes in accordance with the specified design input and document the conformance in a design output.
- Perform design reviews.
- Perform design verification in accordance with the proper procedures.
- Perform design validation in accordance with the proper procedures.
- Develop manufacturing processes for the new or changed designs.
- Design for manufacturing
- Improve existing manufacturing processes.
- Cross functional approval of design verification and validation activities for independent projects.
- Write and execute protocols for testing within the design control process.
- Develops processes for the manufacturing of new products and changes of existing products.
- Responsible for creating Design History Files.

Required Skills

* BSME OR BS in Biomechanical
* Minimum 3 years of experience with New Product Development from concept to launch
* Heavily prefer medical device experience
* Design Controls
* Plastics experience (design and manufacturing)