Senior Medical Device Design Engineer — Hybrid

W. L. Gore & Associates

Arizona

Hybrid

USD 120,000 - 180,000

Full time

7 hours ago

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Job summary

Gore in Phoenix, AZ is seeking an experienced Design Engineer to design new medical products and support existing ones within a cross-functional team of Gore associates and external partners. You will apply DFMA, participate in structured design reviews, and ensure designs meet ISO 10993 and 21 CFR 820 requirements while developing core skills in CAD, GD&T, and material science.

This hybrid role offers collaboration with internal and external stakeholders.

Qualifications

Bachelor’s degree in Engineering or Science; 15+ years in engineering, R&D, or related fields.
SolidWorks modeling and Simulation with CSWP certification.
Mold flow analysis software experience (MoldFlow or Moldex3D).
Experience with R&D development cycles and technical design reviews.
Excellent written and verbal communication with technical audiences.
GD&T, tolerance analyses, and compliance with ASME standards.

Responsibilities

Design, develop, and commercialize innovative medical devices, leveraging DFMA, and drive design reviews.
Work as a core team member to generate concepts and develop detailed designs with cross-functional partners.
Document design development with ISO 10993, 21 CFR Part 820, and ASME Y14.5 considerations.
Maintain expertise in CAD, GD&T, tolerance analysis, and manufacturing methods.
Deliver design packages including specifications, tolerances, CAD models, materials, and analyses.
Represent device design and inspection needs to suppliers.