Position Summary:
Seeking a Subject Matter Expert (SME) in Injection Moulding Process Development to lead and optimize the end-to-end development of injection moulding processes for plastic components used in medical devices.
Key Responsibilities:
Lead the design, development, and validation of injection moulding processes for new and existing medical device components.
Define and develop robust process parameters and scientific moulding strategies
Own the execution of moulding process characterization, DOE studies, and process optimization activities.
Partner with engineers and external suppliers to develop and optimize mould designs for manufacturability and quality.
Analyze and interpret moulding data (e.g. cavity pressure, temperature, cycle times) to ensure process control and repeatability.
Author and review technical documentation including process development plans, protocols, reports, and SOPs.
Drive continuous improvement efforts focused on yield enhancement, cycle time reduction, and scrap minimization.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory and quality standards.
Qualifications and Experience:
Bachelor's or Master's degree in Plastics Engineering, Mechanical Engineering, Polymer Science, or similar.
Minimum 7-10 years of hands-on experience in injection moulding process development, specifically within the medical device industry.
Strong expertise in scientific injection moulding techniques, including over-moulding.
Proven experience with process development
Familiarity with medical-grade thermoplastics, bio-compatible polymers, and micro-moulding technologies.
Deep understanding of quality systems and regulatory standards applicable to medical device manufacturing.
