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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