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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Design Assurance Engineer


Reference:TG - SDA - Galway Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Design Engineer, Lead Quality Engineer, QA Specialist, QE Manufacturing Engineer, Quality Assurance Technologist, Quality Specialist

Job title:Senior R&D Engineer
Location:Parkmore Business Park, Galway.
Benefits:Excellent salary and benefits also an opportunity to grow your career with hugely exciting Medical Device start up.

Company:
My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that will focus initially on patients with Critical limb ischemia.


About the role:
As a Senior R&D Engineer you 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.



Requirements:
- Level 8 engineering, science, or equivalent degree.
- 5+ 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.
- Working knowledge of biocompatible metal and/or polymer materials.



Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]