Your responsibilities

Designs and develops new implants and instrumentation and develops improvements and modifications to current products

Interacts with surgeons and internal functional departments to define and develop product requirements and concepts

Supports project lead and other core team members in commercialization of product.

Generates product models, concept layouts, and prints using a CAD software.

Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies

Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing

Works with manufacturing during the design stages to incorporate manufacturability into the product designs

Responsible for all the designs from concept development through product launch.

Responsible for initial patent review of designs for freedom to operate

Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times

Your qualifications

3-5 years of experience in the design and development of mechanical products

Knowledge of CAD software (SolidWorks, Pro-E, etc.) preferred

BS Biomedical Engineering, BS Mechanical Engineering, BS MET (or equivalent) required

Experience in medical device industry desirable

Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel

Demonstrated creative design ability

Demonstrated success in developing finished design specifications