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About the Role:
We are looking for a Design Engineer to join our Medical Packaging team. In this role, you will design new packages for medical products or support existing products with a diverse, cross-functional team of Gore associates and external suppliers. You will be an integral contributor to the success of Gore's medical product portfolio, this position will involve interactions with a variety of disciplines across the Medical Division.
This position will be located at a facility
in
Flagstaff or Phoenix, Arizona , with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
Responsibilities:
Design, prototype, and construct innovative user interface packages for medical devices, making use of both new and existing technologies while incorporating Design for Manufacture and Assembly principles (DFMA)
Work closely with new product development teams and external design partners on defining user needs and translating them into design inputs; including support creation of functional prototypes, design evaluation, part/assembly specifications, design for manufacturability assessments, and component procurement through all phases of product development
Document design development/exploration efforts within a quality system using good engineering practices (e.g. research, peer review, statistical data evaluation, etc.)
Incorporate existing standards (e.g. ISO11607-1) into design requirements surrounding the regulatory requirements for medical devices
Develop and maintain a fundamental understanding of the portfolio of package designs, capabilities, and materials in order to incorporate best practices and support standardization; including the support of existing commercial product lines through technology transfers, specification updates and improvements, and input on CAPAs, NCRs, or other areas where the design may be impacted
Deliver package designs which include development specifications, material sets, test methods, and validation and verification of designs
Support the supplier selection process and represent the technical needs of the package to suppliers and Gore's strategic sourcing teams, including conducting technical assessments of relevant suppliers
Support product teams and supplier engineers in risk analyses through the Design Control process in order to mitigate patient risks
Provide technical input and review on projects within the Packaging team; including ideas for applications of technologies and features with other designers, platform members and product teams
Understand core material sets and manufacturing methods for medical packages
Required Qualifications:
Bachelor's Degree in Mechanical Engineering or Packaging Engineering Degree AND a minimum of 2 years experience in the design and sourcing of parts for medical packages
Experience with part and assembly design, associated tolerance analyses and CAD modeling (preferably SOLIDWORKS or AUTOCAD)
Experience prototyping, testing, and documenting the performance of medical device packages consistent with ISO11607 requirements
Excellent verbal and written communication skills; including technical and non-technical audiences
Strong project management skills with an adaptable and team-oriented working style
Demonstrated ability to identify, initiate, and drive technical projects to completion meeting established timelines
Demonstrated ability to help coordinate efforts with product development teams, external part and assembly suppliers, external design firms, and commercial support teams
Ability to travel up to 5%
Desired Qualifications:
Experience meeting established Design for Manufacturability and/or Ergonomic targets
Experience with formal risk assessments and mitigation
Problem solving, Failure Investigation
or
Root Cause Investigation
Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.
What We Offer:
Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at
gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.
Copyright 2024 W. L. Gore & Associates, Inc.
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