Process Engineer - Hybrid, Acuseal, Vascular Graft

Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries, including medical devices, fabrics, electronics, and manufacturing, for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.

Job Description

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 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 2002.

If you are searching for a company where you can make a difference, we're looking for you. In this role, you will work with manufacturing and development teams and other technical associates to establish new processing capability and carry out engineering studies in support of developing and commercialized products.

The ideal candidate will:

• Be passionate about providing engineering support for 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

Responsibilities include:

• Performing and writing validations of products, processes, and equipment in accordance with FDA and 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 medical products and their manufacturability
• Evaluating proposed improvements to processes and products based on analyses of regulatory requirements, product-quality needs, ergonomics, safety, environmental requirements, and economics
• Driving efficient scale-up of manufacturing processes
• Developing and carrying out performance tests on devices to characterize and document their performance to specifications
• Designing, building, and testing prototypes
• Documenting work via reports, technology notebooks, and design file entries
• Writing procedures and training and assisting technical associates

Qualifications

Required Job Qualifications

• Degree in engineering or transferable science, OR at least 5 years of experience in an engineering capacity in the medical-device or pharmaceutical industry
• Solid knowledge of engineering fundamentals and ability to apply this knowledge to manufacturing and product design
• Knowledge of the fundamentals of statistics
• Working understanding of GMP and ISO 9000 requirements
• Demonstrated excellent written and oral communication and presentation skills
• A work style of hands-on involvement with all phases of projects
• Strong mechanical aptitude
• Demonstrated ability to prioritize, initiate, and drive projects to completion
• Ability to:
• Perform machine/process troubleshooting
• Work effectively in team situations as well as independently
• Ability to network and interact effectively with a broad range of associates spanning varied disciplines and responsibilities

Desirable Job Qualifications

• Hands-on experience in process engineering for medical products
• Working knowledge of drawings, specifications, and dimensional tolerances
• Ability to travel periodically

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

EEO/AA Employer

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To apply:

https://wlgore.taleo.net/careersection/2/jobdetail.ftl?lang=en&job=123017