Injection Molding Tooling Engineer

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

Own the design, qualification, performance and lifecycle of precision injection molds used in Ambu medical-device manufacturing in Juárez. Ensure reliable, compliant and cost-effective tooling while supporting new products, capacity expansion and global technology transfers.

Responsibilities and Essential Functions:

• 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 Noblesville, Penang, Xiamen 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.

Qualifications:

• Bachelor's degree in mechanical, Manufacturing, Plastics or related Engineering preferable or technical certification in a related field; 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.
• Working knowledge of DOE/SPC, PFMEA, validation/change control and regulated manufacturing; strong supplier/project coordination; Spanish and technical English.
• Process/product transfer experience preferable.

Authorities:

Recommend tooling specifications, repairs, supplier acceptance and investments within approved procedures; accelerate and request production holds for tooling-related quality or safety risks. No independent budget or personnel authority unless delegated.

Manufacturing/tooling setting with heated molds, machinery, noise and controlled hazards; comply with PPE, EHS, lockout/tagout and cleanliness requirements. Occasional travel may be required.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.