Extrusion Process Engineer 8/27/2016
W.L. Gore & Associates, Inc.
JOB DESCRIPTIONAPPLY Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our diverse portfolio includes everything from high-performance fabrics and implantable medical devices to industrial manufacturing components and aerospace electronics. Through our product leadership, we've been changing lives and changing industries for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.
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 a Process Engineer with a technical background in thermoplastic extrusions specifically as it relates to the design of reinforced tubing, catheter-based component delivery systems, and catheter assemblies to join our team in Flagstaff, AZ.
Just 150 miles north of Phoenix and 80 miles south of the Grand Canyon, Flagstaff is an ideal place to join Gore and change. Surrounded by pine forests and mountains, Flagstaff offers natural beauty, small-town charm, a vibrant educational community, and a diverse culture. Outdoor enthusiasts enjoy all four seasons here, with 300 days of sunshine and a variety of recreational activities. A major employer in Arizona's growing bioscience sector, Gore has led Flagstaff's growth in medical device jobs since 1975.
If you are searching for a company where you can make a difference, were looking for you. In this role, you will interface with the manufacturing and the technical teams to support existing and new product introduction timelines, as well as effectively interact with teams, both internally and externally. You will also become technically competent in existing product platforms and capabilities, including some of Gores new product platforms, through the course of your project work.
* Effectively identifying and transitioning new technologies into new product development efforts
* PARTNER INTERNALLY AND EXTERNALLY TO DEVELOP EARLY R&D PROTOTYPES AND INITIAL MANUFACTURING PROCESSES. PARTNER TO ESTABLISH LONG TERM EXTERNAL MANUFACTURING PROCESSES AND SUPPLY.
* Partnering with various MPD Product Teams on new product development efforts
* Engaging in hands-on experimental design and execution, statistical analysis, prototype generation
* Facilitating tool designs and modifications as necessary to meet quick turn prototyping requirements
* Determining the appropriate material (selection), evaluation and validation as it relates to new product development requirements
* Partnering with Supply Development Engineers and other associates to provide catheter design and processing subject matter expertise
* Driving and ensuring the efficient scale-up and validation of new products into manufacturing processes
* Participating in the development, troubleshooting and continuous improvement of manufacturing processes and equipment
* Creating procedures and providing training and coaching to other technical and manufacturing associates
* Gaining an understanding of existing extrusion processing and reinforcement technologies associated with manufacturing & new product development (includes fundamental understanding of the use of extruded tubes in catheters and other medical applications)
* Applying tools such as Stage Gates NPD Process(es), product concepts and real/win/worth
* Evaluating proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, ergonomics, safety, environmental and economics
* Applying experience and process knowledge while operating within the following systems: quality, complaints, corrective and preventive action, risk management, non-conforming product, design control and supply chain
* Utilizing the MPD quality system for appropriate documentation and implementation of the efforts listed above
* Adapting to rapidly changing objectives in support of key strategic programs
* Building and maintaining Gores intellectual property portfolio
REQUIRED JOB QUALIFICATIONS:
* A Bachelors degree in Engineering or Science
* Minimum of 5 years of experience in thermoplastic extrusion
* Solid knowledge of engineering fundamentals and a proven ability to apply it
* Knowledge of:
* Product development and manufacturing
* Extrusion tool design and applications
* Statistical-based analysis (and experience with)
* A work style of hands-on involvement with all phases of his/her projects
* Strong initiative self-directed and takes action on opportunities
* Ability to stick with a problem until it is resolved and will work additional hours if needed to accomplish the goal
* Ability to work with supply development engineers and external vendors to establish and ensure long manufacturing supply.
* Desire to engage in short-run specialty product manufacturing
* Demonstrated ability to:
* Troubleshoot and resolve technical issues
* Prioritize, initiate, and drive projects to completion
* Communicate with excellence, both written and orally, with the ability to overcome conflict
* Effectively interface, network and influence cross-functional associates in manufacturing, quality assurance, regulatory, product specialist, technical and plant leadership
DESIRED JOB QUALIFICATIONS:
* Advanced technical degree
* Medical device and/or pharmaceutical experience in the area(s) of:
* New product design and materials
* Product development
* Process development
* Working understanding of GMP and ISO requirements
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the US. Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA Employer. (Applies to all positions in the U.S.)
KEYWORDS: Gore, job, Elkton, Maryland, MD, medical device, medical, pharmaceutical, engineer, design engineer, engineering, design, designing, manufacture, manufacturing, FDA, GMP, CGMP, CGMPs, ISO, ISO9000, extrusion, injection, fixture, tool, tooling, die, molding, plastic, thermoplastic, single lumen, multi-lumen, tube, plastics, polymer, non-woven, fibers, melt processing