Tooling Engineer

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.
• 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