Position Title: Senior R&D Engineer
Position Summary
The Senior R&D Engineer will be responsible for the design & development of electromechanical
interventional devices. The successful candidate will provide technical leadership and maintain the Design
History File and associated documentation.
Responsibilities
• Lead and be an integral part of the team tasked with the product development process from concept
generation 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 quality
standards, 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, budget
and 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 track
record of leading teams in device development.
• Experience in coordinating and leading Design Reviews and the compilation of associated
documentation.
• Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design
Control requirements.
• Proven experience working with catheter technology, catheter design, testing and manufacturing a
distinct 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 and
change over time.