Engineer/technology D
W. L. Gore & Associates (Flagstaff, Arizona)

This job posting has expired.

You may wish to try a search for Engineer/Technology D

Or visit the FlipDog home page
 

W.L. Gore & Associates, Inc. is looking for a Quality/Reliability Engineer to support several products in the Kendrick Peak facility at various stages of development. The primary focus of this position is the fundamental understanding of testing modalities and the development of these modalities for the evaluation of fitness for use of materials, designs, processes, and products.
 
Expectations include;
Gain an understanding of mechanical testing of catheter-based delivery systems, stents and stent grafts;Development and validation of test methods and specifications, conduct data analysis and experimental design;Ability to translate in-vivo loading conditions to in-vitro tests;Fixture design for special testing, fundamental understanding of device use;Component and product specification development including clinically relevant rationales;Evaluation of prototypes and final product in a simulated clinical environment;Broad interaction with diverse team members;Responsibility for the mechanical test laboratory administration;

Skillful time management and an ability to participate in several projects at once are critical. Should possess excellent writing and presentation skills

 
 Critical success factors are:
A work style of hands-on involvement with all phases of his/her projects;Demonstrated ability to prioritize, initiate, and drive projects to completion;Knowledge of the fundamentals of engineering, physics, and statistical analysis;Ability to work effectively in team situations as well as independently;Ability to network and interface across varied disciplines and responsibilities;Working understanding of GMP and ISO 9000 requirements;Willingness to learn and ability to understand established test methods and requirements applicable to catheter based delivery systems;Ability to adapt/modify established test methods and/or requirements of medical devices. A technical degree is required with Mechanical Engineering, Chemical Engineering, or Material Science/Engineering preferred. A minimum of 5 years of experience in a Reliability engineering capacity in the medical device industry is also preferred.
 
Previous hands-on experience with interventional medical products and medical products quality systems is preferred. Familiarity with interventional device standards and guidance documents is a significant plus. A “hands-on” working style is needed for success. Knowledge of the fundamentals of engineering, physics, and excellent written and verbal communication skills are essential.
 
The position requires a willingness to learn and a hands-on approach as a team member throughout all phases of project development. The ability to set and meet aggressive timelines is required. Individual thinking with team integration is essential.