Provide hands-on tooling support for injection molds used to produce medical device components in an FDA 21 CFR 820 / ISO 13485 environment.

Support mold qualification, maintenance, repair, and NPI tool introduction at the Tijuana site.

Key Responsibilities

- Perform preventive and corrective maintenance, repair, and adjustment of multi-cavity and hot-runner injection molds.

- Disassemble, inspect, clean, and reassemble molds; identify wear, damage, and root causes of tooling-related defects (flash, short shots, sink, gate vestige, ejection issues).

- Support new mold introduction (NPI): mold receiving, FAT/FOT support, trials, and steel-safe correction loops with toolmakers.

- Support IQ/OQ/PQ validation activities with tooling records, dimensional inputs, and trial documentation.

- Coordinate with mold suppliers on tool corrections, spare inserts, and engineering changes.

- Maintain mold history records, spare parts inventory, and tooling documentation in compliance with GDP and the quality system.





- Read and interpret 2D drawings and 3D models (GD&T;); support dimensional analysis with metrology and quality teams.

- Collaborate with process, quality, and production teams on downtime reduction and tooling-related improvements.

- Follow EHS and clean room procedures.

Requirements

- Currently studying Mechanical, Mechatronics, or a related Engineering degree, with a realistic path to graduation in the near future.

- Technical background as a mold maker / toolmaker or tooling technician in injection molding.

- Minimum 3 years of experience.

- Hands-on knowledge of injection mold construction: cavities/cores, slides, lifters, ejection systems, cooling, hot runner systems.

- Machining fundamentals (milling, grinding, polishing; EDM is a plus).

- Ability to read technical drawings and use measuring instruments.

- English level: 80% technical English proficiency.

- Availability to support trials and urgent tooling issues per business need.

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📌 Tooling Technician (Injection Molds) (Tijuana)
🏢 Icu Medical
📍 Tijuana