Lead the design, development, and implementation of injection molds, tooling, fixtures, and related equipment for medical plastic components.
Collaborate with Program Management, Manufacturing Engineering, and Quality teams during new product launches, mold development, sampling, and production readiness activities.
Support mold qualification, process validation, and verification activities, ensuring appropriate documentation and compliance with customer and quality system requirements.
Lead root cause analysis and implement corrective actions for tooling-related issues affecting product quality, cycle time, scrap, and production efficiency.
Establish and improve preventive maintenance strategies, mold repair plans, tooling life tracking, and spare parts requirements.
Identify opportunities to improve mold performance, reduce downtime, optimize cycle times, minimize scrap, and increase overall equipment effectiveness.
Coordinate with external mold makers and tooling suppliers regarding mold design reviews, fabrication, repairs, modifications, delivery schedules, and technical requirements.
Ensure tooling-related activities comply with applicable procedures, change control requirements, risk management practices, and ISO 13485 quality management system requirements.
Develop and maintain tooling specifications, mold drawings, maintenance records, engineering change documentation, and technical reports.
Provide technical guidance and mentorship to engineers, technicians, and cross-functional teams on tooling design, mold performance, and troubleshooting methodologies.
Support engineering changes, mold modifications, and tooling transfers to ensure smooth implementation into production.
Participate in technical reviews, process improvement initiatives, and cross-functional projects to improve manufacturing performance and product quality.
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechatronics, Plastics Engineering, or a related technical field.
Minimum of 5 years of experience in tooling engineering, injection mold design, mold development, or tooling maintenance within a manufacturing environment.
Strong knowledge of plastic injection molding processes, mold construction, mold components, and tooling troubleshooting.
Experience interpreting engineering drawings, GD&T;, mold designs, and technical specifications.




Knowledge of mold maintenance, repair methodologies, and tooling performance optimization.
Experience working with cross-functional teams in a manufacturing environment.
Intermediate to advanced English proficiency for technical communication with international teams and suppliers.
Strong analytical, problem-solving, organizational, and communication skills.

Key Responsibilities
Lead the design, development, and implementation of injection molds, tooling, fixtures, and related equipment for medical plastic components.
Collaborate with Program Management, Manufacturing Engineering, and Quality teams during new product launches, mold development, sampling, and production readiness activities.
Support mold qualification, process validation, and verification activities, ensuring appropriate documentation and compliance with customer and quality system requirements.
Lead root cause analysis and implement corrective actions for tooling-related issues affecting product quality, cycle time, scrap, and production efficiency.
Establish and improve preventive maintenance strategies, mold repair plans, tooling life tracking, and spare parts requirements.
Identify opportunities to improve mold performance, reduce downtime, optimize cycle times, minimize scrap, and increase overall equipment effectiveness.
Coordinate with external mold makers and tooling suppliers regarding mold design reviews, fabrication, repairs, modifications, delivery schedules, and technical requirements.
Ensure tooling-related activities comply with applicable procedures, change control requirements, risk management practices, and ISO 13485 quality management system requirements.
Develop and maintain tooling specifications, mold drawings, maintenance records, engineering change documentation, and technical reports.
Provide technical guidance and mentorship to engineers, technicians, and cross-functional teams on tooling design, mold performance, and troubleshooting methodologies.
Support engineering changes,



mold modifications, and tooling transfers to ensure smooth implementation into production.
Participate in technical reviews, process improvement initiatives, and cross-functional projects to improve manufacturing performance and product quality.

Minimum Requirements
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechatronics, Plastics Engineering, or a related technical field.
Minimum of 5 years of experience in tooling engineering, injection mold design, mold development, or tooling maintenance within a manufacturing environment.
Strong knowledge of plastic injection molding processes, mold construction, mold components, and tooling troubleshooting.
Experience interpreting engineering drawings, GD&T;, mold designs, and technical specifications.
Knowledge of mold maintenance, repair methodologies, and tooling performance optimization.
Experience working with cross-functional teams in a manufacturing environment.
Intermediate to advanced English proficiency for technical communication with international teams and suppliers.
Strong analytical, problem-solving, organizational, and communication skills.

Desired Skills and Qualifications
Experience in medical device manufacturing or another highly regulated manufacturing environment.
Familiarity with ISO 13485, Good Manufacturing Practices (GMP), and medical device quality management systems.
Experience with CAD software such as SolidWorks, AutoCAD, or equivalent mold design tools.
Knowledge of mold flow analysis and Design for Manufacturability (DFM).
Experience with scientific molding principles and injection molding process optimization.
Knowledge of IQ/OQ/PQ, process validation, and equipment qualification.
Experience with PFMEA, root cause analysis, Corrective and Preventive Actions (CAPA), and risk management tools.
Knowledge of hot runner systems, multi-cavity molds, and precision tooling.
Experience managing tooling projects, budgets, timelines, and external suppliers.
Familiarity with engineering change control and technical documentation requirements.
Experience supporting new product introduction (NPI) and process development activities.
Strong leadership skills, attention to detail, and the ability to manage multiple projects simultaneously.

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📌 Sr. Tooling Engineer (Tecate)
🏢 Formula Plastics
📍 Tecate