Engineering Consultant I/II – R&D (Medical Device)

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 engineering records.

Key responsibilities

• Review and perform gap analysis on documentation such as BOMs, design matrices, validation/verification protocols, risk management files, and test methods.
• Maintain and update the Design History File, including Design Inputs/Outputs, Verification, Validation, and CAPA/NC records.
• Prepare and keep a Project Tracker with weekly updates for management review.
• Facilitate knowledge transfer to the client during and after project completion.
• Execute additional tasks agreed upon with project liaisons.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 3 years of relevant experience.
• Advanced proficiency with MS Office applications (Word, Excel, PowerPoint, Project, Visio).
• Fluent in English (reading, writing, speaking) and native Spanish speaker.

Required skills

• Minitab statistical analysis.
• SolidWorks, ProE or Inventor for 3D modeling and prototyping.
• Experience with electronic document management systems.
• Statistical analysis and tolerance analysis capabilities.