Tooling Technician (Injection Molds)

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.