About the Role

We are looking for a Design Engineer to join our team. In this role, you will design 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. Diversity is a core value at Gore. We are passionate about building and sustaining an inclusive and equitable work environment for all Associates. We believe every member of our team enriches our work environment by exposing us to a broad range of perspectives to understand and engage with our customers, suppliers, and each other.

This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• 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 effort 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

Required Qualifications

• Bachelor’s degree in Engineering or Science discipline (e.g., Mechanical Engineering, Biomedical Engineering, Physics, etc.) with 4 years of experience, or Master’s degree in Engineering with 2 Year of experience
• Proficiency with CAD software (e.g., Solidworks, CREO, etc.)
• Experience with R&D development cycles and participating in technical design reviews, either providing technical input or incorporating feedback on design outputs
• Experience developing and documenting product specifications in compliance with ASME standards and applicable quality system requirements
• Experience with data-driven decision making and structured problem-solving techniques to determine root cause and identify countermeasures
• Excellent verbal and written communication skills with both technical and non-technical audiences
• Demonstrated ability to apply engineering evaluation methods, such as tolerance analyses, material assessments, and performance testing, that inform design direction
• Demonstrated ability to complete projects per quality system requirements that balance customer service, fitness for use, manufacturability, and time to market
• Demonstrated ability to foster an inclusive environment that engages and empowers fellow Associates
• Ability to travel up to 10%

Desired Qualifications

• Experience with nitinol stent design, catheter design, injection molded component design, prototyping, manufacturing, and/or testing
• Software skills (e.g. Solidworks CSWA or CSWP, ABAQUS, Python, Rhino, Grasshopper, Simpleware, JMP statistical analysis)
• Ability and willingness to learn new technical skills and apply them to product development activities with significant technical uncertainties and tight timelines

This position offers a hybrid work arrangement in the country from which the Associate is employed.  Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.