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