Senior Engineering Consultant – Process Development (Medical Device)

About the role

This position supports design development activities for medical devices, focusing on accurate documentation and compliance within the Design History File. You will work closely with cross‑functional teams to ensure traceability, risk management, and timely updates throughout the product lifecycle.

Key responsibilities

• Review documentation and perform gap analysis on BOMs, complaints, design matrices, validation/verification protocols, risk management files, and more.
• Maintain and update the Design History File, including design inputs/outputs, verification, validation, risk management, and CAPA/NC.
• Prepare and keep a project tracker with weekly updates for management review.
• Facilitate knowledge transfer to the client during and after project completion.
• Collaborate with cross‑functional teams to gather, organize, and ensure traceability of technical documentation.

Required profile

• Bachelor’s degree in Engineering.
• At least 8 years of experience in process development or engineering consulting for medical devices.
• Fluent in English (reading, writing, speaking) and native Spanish.

Required skills

• Advanced proficiency with MS Office applications (Word, Excel, PowerPoint, Project, Visio).
• Statistical analysis using Minitab.
• 3D CAD tools such as SolidWorks, ProE or Inventor.
• Experience with electronic documentation management systems.