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Tooling Engineer II

ICU Medical

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. In lieu of a degree a combination of training and experience will be considered. Min 3 - 5 yrs. experience in the Medical Device or Engineering 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 preferred. Prior experience with mold or line insourcing, technology transfer, or multi-site project coordination is a strong plus.

Octubre 07 2026 en Tijuana