Sr Tooling Engineer

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.

Key Performance Indicators (KPIs)

• Tooling downtime and mold availability.
• Mold-related scrap and defect rates.
• Preventive maintenance compliance.
• Mold repair turnaround time.
• Tooling project completion within established schedules and budgets.
• Successful mold qualification and process validation.
• Reduction in cycle time and tooling-related production costs.
• Improvements in mold life, reliability, and overall equipment effectiveness.
• Effectiveness of corrective actions and continuous improvement initiatives.

Sueldo: $3,000.00 - $3,700.00 al día

Beneficios:

• Caja de ahorro
• Días por enfermedad
• Estacionamiento de la empresa
• Seguro de gastos médicos mayores
• Servicio de comedor
• Vales de despensa

Lugar de trabajo: Empleo presencial