The Medical Products Division of W. L. Gore & Associates, Inc. is seeking an experienced Process Engineer to carry out engineering studies and changes in support of current commercialized products and/or new product development for the Vascular Graft product Families. The person will work in conjunction with manufacturing and development teams and with other technical associates. Activities in the scope of the position include but are not limited to:
· Performing and writing validations of product, 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 a medical product and its manufacturability,
· Evaluating proposed improvements to processes and products based on analyses of regulatory requirements, product quality needs, ergonomics, safety, environmental and economics,
· Driving the efficient scale-up of manufacturing processes,
· Developing and carrying out performance tests on a device to characterize and document its safety,
· Designing, building and testing prototypes,
· Documenting work via reports, technology notebooks, and design file entries,
· Writing procedures, training other associates, and assisting other technical associates.
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,
· Solid knowledge of engineering fundamentals and ability to apply this knowledge to manufacturing and product design,
· Knowledge of the fundamentals of statistics,
· Ability to work effectively in team situations as well as independently,
· Demonstrated excellent communication skills, both written and oral,
· Ability to network and interface effectively with a broad range of associates spanning varied disciplines and responsibilities, and
· Working understanding of GMP and ISO 13485 requirements.
A degree in Science or Engineering is required. Excellent written, oral and presentation skills are required. At least 3 years experience as a process or manufacturing engineer is required.
Desirable attributes:
· Demonstrated successful application of Lean Tools for continuous improvement of processes and products.
· Previous hands on experience in process, quality or reliability engineering,
· Previous hands-on experience with medical products, and
· A willingness to travel periodically.
· An advanced technical degree,
Must have the legal and ongoing authority to work in the US.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
EEO/AA Employer (applies to all positions located in the U.S.)