Lead Injection Molding Tooling Engineer (Medical Devices)

Ambu A/S; Ciudad Juárez; On-site; MXN 420,000 - 660,000; Full time

Job summary

Ambu A/S in Juárez seeks an experienced Mold Tooling Engineer to own design, qualification, and lifecycle of precision injection molds for medical-device manufacturing. You will ensure reliable tooling, drive uptime, and support new product introductions and technology transfers.

The role requires hands-on mold design, trials, and metrology within ISO 13485 and FDA QMSR contexts, collaborating with global toolmakers and process teams to optimize cycle times and costs.

Qualifications

• Bachelor's degree in mechanical, Manufacturing, Plastics or related Engineering; 5+ years in precision injection mold tooling; medical-device experience preferred.
• Hands-on mold design, construction, trials, troubleshooting, CAD/GD&T, thermoplastics, metrology and mold maintenance knowledge.
• Spanish and technical English proficiency; knowledge of DOE/SPC, PFMEA, validation/change control and regulated manufacturing.

Responsibilities

• Lead mold specifications, DFM/design reviews, mold construction, supplier selection, trials, FAT/SAT and production introduction; evaluating cavities, gating, cooling, venting, ejection and tolerances.
• Support new product introductions, mold duplication, transfers and scale-up with global facilities and external toolmakers.
• Troubleshoot mold defects and dimensional variation; partner with Process Engineering and Maintenance on root cause, scientific molding, stable process windows and cycle-time improvements.
• Own mold preventive maintenance requirements, refurbishment, critical spares, shot-count/condition tracking, drawings and tooling change documentation.
• Support risk assessments, PFMEA, NCR/CAPA, metrology, capability studies and IQ/OQ/PQ; maintain approved material, traceability and contamination controls under ISO 13485 and applicable FDA QMSR requirements.
• Drive tooling uptime, yield, scrap and cost improvements; coordinate vendors, tooling CAPEX proposals and technical training for molding personnel.
• Support projects as product/process transfers, process efficiencies and others.

Skills

Mold tooling

Process engineering liaison

Troubleshooting

Regulatory awareness

Spanish & technical English

Education

Bachelor's degree in mechanical, Manufacturing, Plastics or related Engineering

Tools

CAD

GD&T

CMM

Job description

Ambu A/S in Juárez seeks an experienced Mold Tooling Engineer to own design, qualification, and lifecycle of precision injection molds for medical-device manufacturing. You will ensure reliable tooling, drive uptime, and support new product introductions and technology transfers.

The role requires hands-on mold design, trials, and metrology within ISO 13485 and FDA QMSR contexts, collaborating with global toolmakers and process teams to optimize cycle times and costs.