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Job Overview

We are seeking a highly skilled Senior R&D / Product Development Engineer with expertise in product and process design, process optimization and scale-up. This role will be responsible for driving the development and implementation of processes from concept to transfer to production. The ideal candidate will possess extensive experience in process engineering, a strong understanding of catheter shaft manufacturing processes, and the ability to lead teams. The successful candidate will report to the R&D/Product Development Manager and the position will be based in our Medical HQ in Galway.

• Process Development: Lead and be an integral part of the team tasked with the development of catheter shafts from concept through to process validation and transfer to operations
• Process Optimization: Continuously evaluate and improve existing processes to enhance productivity, quality, and cost-effectiveness while maintaining compliance with industry standards and regulations.
• Cross-Functional Collaboration: Work closely with PMO, Operations, Quality, and other departments to ensure smooth handoffs and successful process development and implementation.
• Customer engagement: Build a partnership with, and lead technical content during customer calls and visits.
• Troubleshooting: Address technical issues during feasibility, development, validation, scale-up and manufacturing, providing solutions to design and process challenges.
• Documentation & Compliance: Prepare detailed documentation in line with project needs, regulatory requirements and industry standards.
• Innovation: Drive continuous improvement initiatives, contributing to the development of new technologies, methodologies, and solutions to meet business goals.
• Mentorship: Provide guidance and mentorship to junior engineers and cross-functional teams, fostering a culture of innovation and collaboration.

• Level 8 Engineering, Science or equivalent degree.
• 5+ years industry experience in a Medical NPD environment.
• Experience with Lean Six Sigma, Design of Experiments (DOE), or other process optimization methodologies.

• Proven expertise in key catheter shaft manufacturing techniques - Braiding, coiling, reflow, thermal and adhesive bonding at minimum.
• Excellent problem-solving and troubleshooting skills.
• Proven experience in leading teams performing FMEA's, verifications and validations for medical device products and processes.
• Experience with engineering tools such as DOE, SPC, and using Minitab.
• Working knowledge of biocompatible metal and/or polymer materials.
• Strong interpersonal and communication skills, both written and verbal, with the ability to steer cross-functional teams
• Ability to lead a team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
• Ability to present technical information clearly to both technical and non-technical stakeholders.
• Availability to participate in limited travelling to meet with customers