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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 thomas.gallagher@lifescience.ie