Responsibilities may include the following and other duties as assigned:
· Set up and validate injection molding processes for new and existing products, ensuring optimal cycle times and quality.
· Perform process validations (IQ/OQ/PQ) and maintain compliance with FDA and ISO 13485 requirements.
· Provide hands-on technical support for continuous production, including troubleshooting equipment, material, and process issues.
· Monitor molding operations to maintain consistent performance and implement corrective actions as needed.
· Collaborate with production teams to resolve non-conformances and improve process reliability.
· Develop and maintain detailed process documentation, including setup sheets, validation protocols, and work instructions.
· Apply scientific molding principles and statistical process control (SPC) to optimize process parameters.
· Train and mentor production personnel on molding best practices and process standards.
· Partner with tooling engineers and suppliers to address mold performance issues and implement improvements.
· Drive continuous improvement initiatives to reduce scrap, improve cycle times, and enhance overall efficiency.
· Ensure adherence to safety and environmental regulations in all molding operations.