Design Engineer - Aortic

About the Role

We are looking for a Design Engineer to join our Aortic Design Engineering team. In this role, you will design and document new medical products or support existing products with a diverse, cross‑functional team of Gore associates and external partners. As an integral contributor to the success of Gore’s product portfolio, this position will involve interactions with a variety of disciplines across Gore Medical.

This role will be located at one of our facilities in Phoenix, or Flagstaff, Arizona with the possibility of a hybrid work arrangement.

• Design, develop, and commercialize innovative medical devices and accessories, leveraging new and existing technologies, while incorporating Design for Manufacture and Assembly principles (DFMA). Drive and participate in structured design reviews and act as a formal technical reviewer within the Quality System where appropriate.
• Work as a new product development core team member to generate design concepts and develop them into detailed product designs that meet Design Input Requirements and stakeholder needs, scoping design work in collaboration with cross‑functional partners and driving risk reduction efforts to deliver on project priorities and timelines.
• Drive and document design development efforts using good engineering practices (e.g. research, design and execution of experiments, tolerance analysis, etc.) within a quality system, including incorporating existing industry and regulatory standards (e.g. ISO 10993, 21 CFR Part 820, ASME Y14.5) into design requirements, contributing to the standardization of best practices, templates, and design engineering tools within the function.
• Document designs and concepts for patent or trade secret protection, collaborating with legal/IP functions to submit invention disclosures when appropriate.
• Maintain and grow expertise in core design skills (e.g., CAD, GD&T, tolerance analysis, FEA), pursue relevant certifications (e.g., CSWP, ASME GDTP, CAM-F) and develop an understanding of medical device core material sets and manufacturing methods (e.g., forming, additive, and subtractive manufacturing).
• Deliver design packages which include specifications, tolerance analyses, CAD models, material sets, summaries of the performance, and analyses, data, and rationales supporting the design choices.
• Represent the technical needs of the device design and inspection requirements to suppliers.
• Support commercial product lines through technology transfers, design changes, specification updates and improvements, and input on CAPAs, NCRs, or other areas where the design may be impacted.
• Apply structured problem‑solving techniques to determine root cause for non‑conforming products and design issues (e.g., raw materials, components, assemblies, and systems).
• Develop and maintain a fundamental understanding of the portfolio of Gore device designs, capabilities, materials, and manufacturing methods to incorporate best practices and support standardization.

• Bachelor’s degree in Engineering or Science discipline (e.g., Mechanical Engineering, Biomedical Engineering, Physics, etc.) with 4 years of design experience, or Master’s degree in Engineering with 2 years of design experience.
• Experience with CAD software (e.g., Solidworks, CREO, Rhino/Grasshopper, etc.).
• Experience with R&D development cycles and participating in technical design reviews, either providing technical input or incorporating feedback on design outputs.
• Experience with data‑driven decision making and structured problem‑solving techniques to determine root cause and identify countermeasures.
• Demonstrated ability to apply engineering evaluation methods, such as tolerance analyses, material assessments, and performance testing, that inform design direction.
• Demonstrated experience developing and documenting product specifications in compliance with ASME standards and applicable quality system requirements, including the application of geometric dimensioning and tolerancing (GD&T).
• Demonstrated ability to complete projects per quality system requirements that balance customer service, fitness for use, manufacturability,…