Validation Engineer II - Medical Devices & Process Excellence

ICU Medical Inc; Tijuana; On-site; MXN 360,000 - 480,000; Full time

Job summary

ICU Medical Inc. is seeking an experienced Process/Quality Engineer for our Baja California manufacturing site to ensure production aligns with design requirements for medical devices.

The role requires 3–5 years in manufacturing, a Bachelor’s degree in Engineering, and fluency in English and Spanish. You will develop process flow diagrams, validate production lines, write validation protocols, support audits, and drive continuous improvement in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering required.
• 3–5 years of experience in a similar position.
• Manufacturing experience in the medical device industry.
• Ability to communicate in English and Spanish.

Responsibilities

• Ensure production processes comply with established design requirements.
• Manage projects and activities with medium to high impact.
• Coordinate work teams for project management activities.
• Develop process flow diagrams and production layouts.
• Update or correct manufacturing and product procedures, as required.
• Perform product design testing and process validation.

Skills

Process engineering

Quality systems

Project management

Statistical analysis

Documentation

Education

Bachelor’s degree in Engineering

Tools

MS Office

AutoCAD

MS Project

Visio

Minitab

Job description

ICU Medical Inc. is seeking an experienced Process/Quality Engineer for our Baja California manufacturing site to ensure production aligns with design requirements for medical devices.

The role requires 3–5 years in manufacturing, a Bachelor’s degree in Engineering, and fluency in English and Spanish. You will develop process flow diagrams, validate production lines, write validation protocols, support audits, and drive continuous improvement in a regulated environment.