Mechanical Design Engineers Job in Chester Pennsylvania (PA)

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My client is a very successful and secure Medical Devices manufacturer. The company is seeking Mechanical Design Engineers to join their ever expanding product development department. Overall responsibilities will include the design and development of new products as well as the improvement and modification of current products. Will define, develop, and modify new and existing products by interacting with end-user medical personnel, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments. Will personally develop 3D / Solid Models using top-of-the-line CAD Software within FDA Design Control Regulations, while producing all appropriate compliance documentation, which support 510(k) submissions and/or IDE clinical studies. Will carry out geometric dimensioning and tolerancing and other mechanical design testing tools according to ASTM standards.

REQUIREMENTS:

1. Must have 3 to 10 years of experience in the design and development of Class II or III Medical Device Products
   
2. Must have strong knowledge of FDA Design Control Regulations.
   
3. Design experience involving Internal Fixation is a big plus.
   
4. Must have hands-on 3D Modeling experience using CAD software tools like Pro-E, SolidWorks, Medusa, AutoCad, Ideas, etc....
   
5. BS in Mechanical Engineering (or equivalent) required. A Masters degree is a plus.
   
6. Prior project management experience preferred.
   
7. Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel is a must.
   
8. A Hands-on engineer with demonstrated creative design ability and strong analytical skills.
   
9. Demonstrated success in bringing product from design through introduction on time.
   
10. Travel 20-25% of time
    

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