Tooling Engineer II

ICU Medical Inc; 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

Essential duties and responsibilities

• 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. 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.