R&D Process Development Engineer

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. SUMMARY OF DUTIES Due to continuous growth at our Galway site, an opportunity now exists for an R&D Process Development Engineer to join our R&D group. This exciting opportunity is a key role within R&D and will take a hands-on role in the selection, generation and validation of new process technologies and the further development of existing processing methods. The Process Development Engineer will be a key member of the Product Development Core Team focusing on all process related aspects to ensure the generation and implementation of robust solution from a systems, Equipment and test perspective that will seamlessly transfer in to scale manufacturing. DUTIES & RESPONSIBILITIES Liaise with Project Leaders, R&D, Operations and other internal stakeholders to clearly understand product requirements, process inputs and project deliverables. Lead by example, set standards and provide direction, coaching and development to Engineers and Technicians to build a high‑performance, high‑capability team. Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure process designs are robust, reproducible and capable of meeting all qualification and regulatory requirements. Design and develop production equipment, tooling and fixtures to support new product and process introduction, generate detailed engineering drawings and specifications, and work closely with vendors to ensure equipment is manufactured and delivered to defined technical, quality and project requirements. Collaborate with internal teams and external suppliers to specify, prototype and refine custom fixtures and equipment that support consistent assembly, measurement, handling and testing of components. Ensure Design for Manufacturability, capacity planning and product cost impacts are considered in all decision‑making such that designs can be scaled seamlessly into manufacturing at the required product cost. Define and implement drawings, BOMs, routers and procedures to ensure product design is accurately translated into manufacturing operations. Ensure all equipment and fixturing designs are fully documented, including drawings, tolerances, materials and maintenance plans, and integrated into overall process flows and qualification strategies. Plan and execute risk assessments, process specifications, test method development and subsequent Process Qualifications (IQ, OQ, PQ). Generate and maintain Engineering and Design documentation in accordance with the Quality Management System and applicable regulatory standards. Manage and provide guidance and development to Junior Engineers and Technicians. Perform other related…