Tooling Engineer II: Mold Design & Process Optimization

ICU Medical; Tijuana; On-site; MXN 391,000 - 670,000; Full time

Job summary

ICU Medical in Tijuana, MX seeks an experienced Mold Tooling Engineer to lead tooling initiatives, design for manufacturability, and drive improvements across cycle time, yield, and cost.

You will collaborate with product development, manufacturing, quality, and suppliers, perform FMEA and CAPA, and validate multi-cavity molds using CT scanning and metrology tools. Fluency in English and strong project management are required.

Qualifications

• BS in Mechanical Engineering or equivalent; training/experience acceptable in lieu of a degree.
• 3–5 years in Medical Device or engineering industry.
• Knowledge of mold tooling, silicone molding, and process validation.
• Experience with IQ/OQ/PQ and FDA/ISO regulatory environments.
• Strong communication and cross-site collaboration skills.

Responsibilities

• Lead tooling and molding projects with timelines, budgets, and SMART goals.
• Collaborate with Product Development, Manufacturing, Quality and suppliers.
• Develop tooling procedures and standard work instructions.
• Perform dimensional verification using 3D scans and metrology software.
• Own CAPA activities and drive cost, quality and cycle-time improvements.

Skills

Part design for manufacturability

Mold manufacturing processes

Project scheduling & SMART goals

Problem solving

Cross-functional collaboration

Education

BS in Mechanical Engineering

Training/experience in lieu of degree

FDA/ISO regulatory knowledge (21 CFR 820; ISO 13485)

Tools

SolidWorks

Minitab

ZEISS INSPECT / CMM metrology software

3D scanning tools

Job description

ICU Medical in Tijuana, MX seeks an experienced Mold Tooling Engineer to lead tooling initiatives, design for manufacturability, and drive improvements across cycle time, yield, and cost.

You will collaborate with product development, manufacturing, quality, and suppliers, perform FMEA and CAPA, and validate multi-cavity molds using CT scanning and metrology tools. Fluency in English and strong project management are required.