We are growing and looking for an experienced Process Engineer to support development and manufacturing of assembly automation projects for medical and pharmaceutical delivery devices. Gilero partners with Tecma to operate a medical device manufacturing facility in Tijuana, Mexico. We are currently seeking a Process Engineer to join the TJ team
If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence

Job Summary:
The position is responsible for developing new manufacturing systems for emerging technologies to support the production of medical devices under device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). In this role, you will be responsible for designing and implementing manufacturing processes and supporting projects on a scale that can range from developmental pilots to full commercial production.

Duties:




Specify and manage external build contractors, install, troubleshoot, and validate automated equipment and processes for complex device assembly and testing.
Develop and deliver new manufacturing process capabilities as needed including process selection, characterization and qualification utilizing designed experiment methodology (DOE)
Evaluate new device designs for manufacturability (DFM/DFA)
Establish process flow and line layouts to achieve efficient, adaptable, and scalable manufacturing cells
Utilizes Lean Thinking, Six Sigma and 5S concepts when creating new or improving existing processes.
Specify new process equipment for manual and fully-automated production lines
Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
Generate CAD models for test or assembly fixtures
Establish maintenance requirements for new equipment
Evaluate the impact of new processes introductions on critical envi

📌 Process Engineer- Medical Device Industry (Tijuana)
🏢 Gilero, A Sanner Group
📍 Tijuana