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Packaging Design Engineer - Flagstaff Arizona
Company: W.L. Gore & Associates Location: Flagstaff, Arizona
Posted On: 04/25/2024
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: |
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