Posted: Tuesday Sep 11, 15:05 PDT Updated: Tuesday Sep 11, 15:22 PDT
Senior Design Engineer
Cincinnati
RESPONSIBILITIES
Design and developinstruments for a widevariety of device OEMs
Communication with customers and surgeons understanding the clinical issues
Defining the design parameters
Ensuring the correct product is provided to the customer
Requirements
Ensure compliance with FDA, and to support 510(k) submissions or IDE
clinical studies.
Create and maintain project plans and FDA compliant Design
History Files (DHF) for each project.
Develop appropriate mechanical test protocols and coordinate the
activities required to fabricate test parts and complete mechanical
testing.
Work in conjunction with manufacturing during the design stages to
incorporate manufacturability into the product designs.
Responsible for the all designs from concept development through
product launch.
Perform bench-top development, prototyping, modeling and testing with in
house facilities.
7 to 10 years experience in the Medical Device field developing surgical
devices and or implantable appliances
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