Process Engineer - Injection Molding

Role details

*Process Engineer – Injection Molding*

Position Summary

The Process Engineer – Injection Molding is responsible for developing, optimizing, validating, and sustaining injection molding processes to ensure consistent product quality, operational efficiency, and reliable manufacturing performance. This role provides technical expertise in scientific molding, process troubleshooting, tooling optimization, equipment performance, and continuous improvement. The engineer collaborates with cross-functional teams to support new product introduction (NPI), process validation, automation improvements, and the transfer of new products and processes into production while maintaining applicable quality, safety, and regulatory standards.

Key Responsibilities

• Develop, optimize, and sustain injection molding processes to improve product quality, cycle times, throughput, and overall equipment effectiveness.
• Apply scientific molding principles, design of experiments (DOE), process capability studies, and statistical analysis to establish robust manufacturing processes.
• Troubleshoot molding defects, equipment issues, material variations, and process deviations; conduct root cause analysis and implement corrective and preventive actions.
• Lead molding trials, process development activities, equipment qualifications, and process validations, including IQ/OQ/PQ.
• Optimize mold performance, hot runner systems, auxiliary equipment, and automation, including end-of-arm (EOA) tooling.
• Evaluate the impact of raw materials, part geometry, tooling design, and process parameters on product quality and manufacturing performance.
• Support new product introduction from development through process qualification, production ramp-up, and ongoing manufacturing.
• Establish and maintain process parameters, work instructions, standard operating procedures, and technical documentation.
• Collaborate with Quality, Manufacturing, Engineering, Maintenance, R&D, suppliers, and contract manufacturers to resolve technical issues and improve production performance.
• Implement continuous improvement initiatives focused on reducing scrap, minimizing downtime, improving yield, and lowering manufacturing costs.
• Support mold maintenance, tooling qualification, equipment troubleshooting, and process monitoring initiatives.
• Recommend equipment, tooling, and capital improvements; develop technical justifications and support implementation.
• Ensure processes comply with applicable quality systems, safety requirements, regulatory standards, and good manufacturing practices.
• Maintain accurate process validation records, change controls, and documentation in accordance with established procedures.
• Provide technical guidance and training to manufacturing personnel, technicians, and engineering team members.

Required Qualifications

• Bachelor’s degree in Engineering or a related technical discipline, or equivalent relevant experience.
• Minimum of 5 years of relevant experience in injection molding, process engineering, or manufacturing engineering.
• Strong understanding of injection molding processes, scientific molding principles, and process optimization.
• Demonstrated experience troubleshooting molding defects, tooling issues, and manufacturing equipment.
• Experience with process validation, qualification, and documentation, including IQ/OQ/PQ.
• Strong analytical, problem-solving, root cause analysis, and continuous improvement skills.
• Ability to communicate technical information effectively and collaborate across cross-functional teams.
• Proficiency in reading, writing, and communicating in English.

Preferred Qualifications

and Technical Skills

• Degree in Plastics Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
• Hands-on experience with hot runner systems, mold tooling, and injection molding equipment.
• Experience troubleshooting automation systems, including robotic systems and end-of-arm tooling.
• Familiarity with process monitoring systems, statistical process control (SPC), and process capability analysis.
• Experience with design of experiments (DOE), structured problem-solving methodologies, and corrective and preventive actions.
• Knowledge of dimensional inspection methods, including contact and non-contact measurement systems.
• Experience in medical device manufacturing or another regulated manufacturing environment.
• Understanding of quality management systems, good manufacturing practices (GMP), and controlled documentation.
• Experience supporting new product introduction, process transfers, and production scale-up.