Senior R&D Engineer - Medical Device Start-up
Permanent
Galway
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.
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