Tooling Engineer

ICU Medical Inc; Tijuana; Presencial; MXN 420.000 - 660.000; Jornada completa

Descripción de la vacante

ICU Medical Inc. seeks a Tooling Engineer to lead design, development, and validation of medical device tooling and molds at our Baja California operation.

You will collaborate with Product Development, Manufacturing, Quality, and external suppliers to drive improvements in cycle time, yield, and cost. The role requires hands-on molding experience, Six Sigma/DOE knowledge, and strong English communication to report progress to global stakeholders.

Formación

• BS in Mechanical Engineering or equivalent.
• 3–5 years in a similar role in Medical Device Manufacturing.
• Mold design and tooling leadership experience.

Responsabilidades

• Lead tooling and molding projects with timelines, milestones, and budgets.
• Collaborate with Product Development, Manufacturing, Quality, Maintenance, Metrology/CT Scanning, and external suppliers.
• Lead tooling design reviews and develop tooling FMEAs with mitigation actions.
• Support validation of multi-cavity molds and full-cavity release.
• Own CAPA activities from initiation to closure and supplier actions.
• Apply DOE, Six Sigma, IQ/OQ/PQ, Gage R&R, and capability analysis using Minitab.

Conocimientos

Design for manufacturability

Project management

Cross-functional collaboration

English communication

Educación

BS in Mechanical Engineering

Herramientas

SolidWorks

Minitab

ZEISS INSPECT

3D scanning / CMM metrology

Descripción del empleo

• Support new product tooling initiatives, tool changes, mold design, sourcing, and improvements to existing molds, focusing on manufacturability, cost reduction, quality, yield, and cycle time.
• Collaborate with Product Development, Manufacturing, Quality, Maintenance, Metrology/CT Scanning, and external suppliers to deliver tooling solutions and resolve technical issues.
• Lead tooling and molding projects, managing timelines, milestones, budgets, and SMART goals to ensure on-time completion.
• Lead tooling design reviews, develop tooling FMEAs, identify risks, and implement documented mitigation actions.
• Support phased validation of multi-cavity molds, including single-cavity activation and CT-scan dimensional confirmation before full-cavity release.
• Own CAPA activities from initiation through closure, including supplier corrective actions.
• Apply SPC, DOE, Six Sigma, IQ/OQ/PQ, Gage R&R, normality testing, and Ppk/Cpk capability analysis, using Minitab or similar statistical tools.
• Perform dimensional verification and print-to-model-to-part alignment using 3D scanning, metrology software (e.g., ZEISS INSPECT), and CT scanning.
• Develop tooling procedures and standard work instructions.
• Independently lead cross-functional teams, address technical challenges, and drive measurable improvements in cycle time, first-pass yield, quality, and cost.
• Maintain project trackers and provide proactive weekly status updates without manager follow-up.
• Communicate technical progress, results, and reports in English to cross-site and global stakeholders.

Knowledge and Skills

• Strong knowledge of plastic part design for manufacturability, and plastic processing.
• Knowledge and experience with cold and hot runner high cavitation tools.
• Knowledge of mold manufacturing processes and their capabilities.
• Proficient in Solid works or similar.
• Working knowledge of statistical tools (e.g., Minitab) for DOE, SPC, Gage R&R, and process capability (Ppk/Cpk) analysis, including normality testing.
• Working knowledge of 3D scanning / CMM metrology software (e.g., ZEISS INSPECT) for dimensional verification against print and CAD models.
• Strong skills in project scheduling and SMART-goal based project management.
• Demonstrate problem analysis skills and provide solutions.
• Review and understand tool & product drawings, tolerance stack up, understanding molding processing documents, data collection and analysis and development of standard work instructions.
• Working proficiency in English (written and verbal) sufficient to prepare technical reports and deliver project updates to multi-site and global stakeholders.
• Strong self-management, accountability, and proactive communication — reliably reports project status without prompting.

Minimum Qualifications, Education and Experience

• BS in Mechanical Engineering or equivalent.
• Min 3 - 5 yrs. experience similar role in the Medical Device Manufacturing Industry
• Scientific molding/RJG molding knowledge/training.
• Mold Simulation experience.
• Experience with Silicone Molding.
• Experience with IQ/OQ/PQ process validation in an FDA 21 CFR 820 / ISO 13485-regulated environment
• Prior experience with mold or line insourcing, technology transfer, or multi-site project coordination