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. 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.

Specify and manage external build contractors, install, troubleshoot, and validate automated equipment and processes for complex device assembly and testing. Generate CAD models for test or assembly fixtures Assess and implement process changes as required by customer request, in response to manufacturing quality issues, or design changes. Perform process risk analysis through PFMEA activities to support new or existing processes.

Maintain Device Master

Record (DMR) and ensure documents are complete, accurate,



and current including process routers, inspection plans, temporary deviations, and non-conformances. Support quality audits of manufacturing processes Lead project activities through the management of budgets, resources, timelines, and deliverables Minimum 3 years relevant experience in manufacturing medical devices. Knowledge of medical device regulations (FDA/ISO) Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software, preferred.

Ability to program PLC, Arduino, or other motion controllers, strong plus.

Experience incorporating vision systems into manufacturing equipment for use in in-process inspection and/or motion control, a plus. Proficient (or better) computer skills, including Excel and Word A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients Commitment to excellence and quality service to external and internal customer Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration.

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