- 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