R&D Engineer – Process Development

About the role

The R&D Engineer (Process Development) reports directly to the R&D Manager / Director of Engineering and is responsible for supporting new product development, establishing new process technologies, and improving existing manufacturing processes, with a strong focus on manufacturability, process capability, and scalability. The R&D Engineer works closely with other R&D functions, Operations, Quality, Project Management, Senior Management, and other stakeholders to ensure successful development and transfer of robust manufacturing processes from R&D into production.

Key responsibilities

• Research, develop, evaluate, qualify, and integrate new technologies, manufacturing processes, equipment, and materials in accordance with product specifications, applicable external standards, internal procedures, design requirements, quality requirements, and project objectives.
• Develop and strengthen internal technical capabilities and engineering expertise in medical tubing extrusion, film casting, coating processes, and related manufacturing technologies.
• Design and execute engineering studies, feasibility studies, Design of Experiments (DOE), and process characterization activities to establish critical process parameters and achieve robust manufacturing processes with acceptable process capability.
• Develop fundamental process and design data, define operating conditions and process windows, and establish critical process parameters (CPPs), critical limits, and safety and quality requirements for manufacturing processes.
• Support process scale-up from development to production and ensure that processes are designed for manufacturability, repeatability, reliability, scalability, and cost effectiveness.
• Develop and execute process qualification and validation strategies, including preparation of protocols, qualification plans, acceptance criteria, and technical reports, in collaboration with Quality and Operations.
• Evaluate materials, components, tooling, and manufacturing processes through analytical testing and engineering studies. Analyze and interpret experimental and manufacturing data to identify trends, risks, and improvement opportunities.
• Troubleshoot complex manufacturing and process-related issues using structured engineering and root-cause-analysis methodologies and implement effective corrective and preventive solutions.
• Prepare and maintain comprehensive technical documentation, including engineering study reports, process specifications, work instructions, process qualification documents, risk assessments, and technology-transfer documentation.
• Provide technical support and engineering guidance to Operations during pilot builds, validation activities, production ramp-up, and continuous process improvement.

About you

• Bachelor's Degree or Master's Degree in chemistry, chemical Engineering, material sciences or equivalent.
• Strong self-discipline, ownership, accountability, and initiative in managing assigned tasks and achieving project objectives.