Senior Engineering Consultant – R&D – Medical Device

About the role

The Senior Engineering Consultant will support design development activities for medical devices, focusing on documentation accuracy and traceability throughout the product lifecycle. You will work closely with cross‑functional teams to ensure the Design History File is complete, compliant, and up‑to‑date.

Key responsibilities

• Review and perform gap analysis on documentation such as 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 records.
• Prepare and maintain a weekly Project Tracker for management review.
• Facilitate knowledge transfer to the client during and after project completion.
• Collaborate with liaison teams to address additional tasks defined in the Statement of Work.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 8 years of relevant experience.
• Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project, Visio).
• Strong statistical analysis skills using Minitab.
• Experience with 3D CAD tools such as SolidWorks, ProE, or Inventor.
• Familiarity with electronic document management systems.
• Native Spanish speaker and fluent in English (reading, writing, speaking).

Required skills

• MS Office suite (Word, Excel, PowerPoint, Project, Visio).
• Minitab statistical analysis.
• SolidWorks, ProE, or Inventor for 3D modeling and prototyping.
• Electronic document management.

What we offer

• Collaborative culture with a welcoming team.
• Flexible employment and benefit options.
• Opportunity to work on challenging medical‑device projects with a global leader in life‑science consulting.