Engineering Consultant II – Manufacturing (Medical Device)

About the role

ECI is seeking an Engineering Consultant II to support its Manufacturing Engineering team on medical‑device projects. The consultant will focus on remediation of manufacturing process controls, validation documentation, and risk‑assessment activities.

Key responsibilities

• Perform gap assessments on Product Risk Assessments (PRA) and pFMEAs to verify validation status and in‑process controls.
• Review and update existing validation documents (OQ/PQ, test methods, software validation) and identify discrepancies.
• Revise, create, and execute validation protocols, reports, work instructions, and test runs.
• Maintain audit‑ready records aligned with the internal Quality Management System.
• Collaborate with Manufacturing and Quality teams, communicate progress, and provide documentation updates.

Required profile

• Bachelor’s degree in Engineering.
• Minimum 4 years of relevant experience.
• Fluent in English (reading, writing, speaking) and native Spanish.

Required skills

• Advanced MS Office skills (Word, Excel, PowerPoint, Project, Visio).
• Proficiency with Minitab for statistical analysis.
• Familiarity with electronic document management systems.

What we offer

• Collaborative culture with flexible employment options.
• Opportunities to work on challenging life‑science projects.