Engineering Consultant II – Medical Device Experience

About the role

This position supports design development activities for medical device projects, focusing on accurate documentation within the Design History File. You will collaborate with cross‑functional teams to ensure compliance, traceability, and timely updates of design inputs/outputs, verification, validation, risk management, and CAPA/NC records.

Key responsibilities

• Support stack analysis and design of plastic parts using SolidWorks.
• Create and manage 3D drawings, assemblies, and dimensions in SolidWorks, and maintain CAD models via SolidWorks Vault.
• Develop test methods, generate protocols, prepare work instructions, and conduct sample preparation.
• Train appraisers, execute test method validation, generate reports, and provide DV testing support.
• Maintain a project tracker with weekly updates for management review.
• Transfer knowledge to the client during and after project completion.
• Perform additional tasks as agreed in the Statement of Work.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 4 years of relevant experience.
• Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project, Visio).
• Fluent in English (reading, writing, speaking) and native Spanish speaker.

Required skills

• SolidWorks (or ProE/Inventor) for 3D modeling and drafting.
• Minitab for statistical analysis.
• Experience with electronic document management systems.
• Proficiency in MS Office suite.