Gore Product/Process Development Engineer Job

Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 35 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for an experienced New Product Development/Process Engineer to join our team in Flagstaff, AZ.

If you are searching for a company where you can make a difference, we're looking for you. In this role, you will support processing of active pharmaceutical ingredients (APIs) used in combination medical devices. With the success of the GORE PROPATEN Vascular Graft and the use of this bioactive heparin coating on other products, Gore is continuing to invest in further development in this area. This position is a ground-floor opportunity in new technology and product development and will initially require substantial hands-on activities. You will work in a progressive team environment with manufacturing and development teams and other technical associates.

The ideal candidate will:

• Be passionate about developing new, state-of-the art implantable medical devices and manufacturing processes
• Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
• Recognize the importance of building and maintaining strong interpersonal relationships

Additional responsibilities include:

• Designing processes and building and testing prototypes
• Performing and writing validations plans of product, processes and equipment in accordance with Food and Drug Administration (FDA) and International Organization for Standards (ISO) guidelines
• Designing, executing, and analyzing experiments based on statistical techniques
• Developing, troubleshooting, and refining medical-device manufacturing processes and equipment
• Conceptualizing and instituting improvements to a medical product and its manufacturability
• Evaluating proposed improvements to processes and products based on analysis of regulatory requirements, product quality needs, ergonomics, safety, environmental factors, and economics
• Driving efficient scale-up of manufacturing processes
• Developing and carrying out performance tests on a device to characterize and document its safety
• Documenting work via reports, technology notebooks, and design file entries

Qualifications