Product Development Engineer

The Company:

A leading company in the orthopedic market for internal fixation devices. This company develops, manufactures and markets the AO ASIF system of orthopedic instruments and implants, which are used by surgeons to internally repair difficult bone fractures.

Scope of the Job:

Design and develop custom and special order requests. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer.

Responsibilities:

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

2. Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts.

3. Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up.

4. Generates product models, concept layouts, and prints using a CAD software. Apply geometric dimensioning and tolerancing accordingly.

5. 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.

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

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

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

9. Performs other special projects and functions as assigned by the department manager.

Candidate Requirements:

Candidates should have a BS in Mechanical Engineering (or equivalent).

Candidates must have 3 - 7 years experience in design and development of mechanical products experience.

Knowledge of CAD software (Pro-E, Medusa, AutoCad, Ideas, Etc.)

Additional Experience:

Prior project management experience preferred.

Experience in medical equipment 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 bringing product from design through introduction on time.

“Hands-on” engineer.