Position Title: Senior R&D EngineerPosition SummaryThe Senior R&D Engineer will be responsible for the design & development of electromechanicalinterventional devices. The successful candidate will provide technical leadership and maintain the DesignHistory File and associated documentation.Responsibilities• Lead and be an integral part of the team tasked with the product development process from conceptgeneration through to commercialisation.• Participate in trials with physicians to provide clinically relevant feedback on product designs.• Provide technical feedback during frequent interaction with users to optimise product design.• Support the maintenance of product files and other relevant documentation to comply with qualitystandards, including risk management, design control and design verification/validation.• Ensure the application of new and existing technologies to provide the optimum device design.• Input to project plans and lead team to develop devices in accordance with planned activities, budgetand timelines.• Provide mentoring and development support to other team members.• Assist in the development of intellectual property generated by development activities.Requirements• Level 8 engineering, science, or equivalent degree.• 5 to 8 year's industry experience in a medical product development environment with a proven trackrecord of leading teams in device development.• Experience in coordinating and leading Design Reviews and the compilation of associateddocumentation.• Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 DesignControl requirements.• Proven experience working with catheter technology, catheter design, testing and manufacturing adistinct advantage.• Experience with engineering tools such as DOE, SPC, and using Minitab.• Working knowledge of biocompatible metal and/or polymer materials.• Availability to participate in limited travel in support of company objectives and activity.Note: As with all positions, due to the dynamic nature of business, key responsibilities will evolve andchange over time.