Injection Molding Process Engineer

Overview

We are seeking an experienced Process Engineer (Injection Moulding) to join a leading Medical Device manufacturer. The successful candidate will be responsible for developing, optimising, validating, and sustaining injection moulding processes used in the manufacture of high-quality medical devices. This role will play a key part in supporting production, driving continuous improvement initiatives, and ensuring compliance with regulatory and quality requirements.

Working within a cross-functional engineering team, you will collaborate with Manufacturing, Quality, Tooling, Automation, Validation, and R&D functions to deliver robust and efficient manufacturing processes.

Key Responsibilities

• Develop, optimise, and maintain injection moulding processes to achieve targeted quality, yield, and throughput objectives.
• Lead process characterisation activities using scientific molding principles and statistical techniques.
• Troubleshoot process, equipment, and quality issues to identify root causes and implement sustainable corrective actions.
• Support the introduction of new products and technologies from development through to commercial production.
• Execute process validations including IQ, OQ, and PQ activities in accordance with regulatory requirements.
• Generate and maintain process documentation, protocols, reports, SOPs, and technical specifications.
• Drive continuous improvement projects focused on scrap reduction, cycle time improvements, and increased equipment efficiency.
• Analyse process data and identify opportunities to improve process capability and product quality.
• Collaborate with toolmakers, machine suppliers, and automation teams to optimise manufacturing performance.
• Support equipment qualifications, preventive maintenance programs, and process monitoring activities.
• Participate in risk assessments, FMEAs, DOE studies, and Root Cause Analysis investigations.
• Ensure compliance with GMP, FDA, ISO 13485, and company quality standards.
• Support internal and external audits as required.
• Provide technical support and training to production and engineering personnel.