Overview
Research & Development Engineer (Vascular)
We are actively seeking to recruit a Research and Development Engineer to become a key member of the R&D Team within a leading Limerick based Medical Device multinational.
This is an excellent opportunity to advance your career within a fast paced dynamic environment.
Responsibilities
* Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
* Product testing and evaluation, completion of test reports to support design selection.
* Preparation and presentation of design reviews.
* Product and project risk analysis and risk management.
* Development of the Design History File
* Work with Process Development Engineering to introduce/develop new equipment and production processes as required for any new manufacturing techniques.
* Source new materials components and equipment.
* Development of component specifications, inspection methods, bills of materials and manufacturing processes.
* Introduction of new equipment, materials and technologies.
* Work closely with Key Opinion Leaders (KOLs), physicians and product managers to develop innovative medical devices to improve patient care.
* Project lead for assigned research & development projects including technical and project management responsibilities.
Qualifications and Experience
* Third level degree in Mechanical, Biomedical, Science, Design or similar discipline.
* 3+ years’ design experience in medical device roles.
* Project planning skills.
* Execution of project in a timely effective manner.
* Knowledge of anatomy and physiology.
* Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
* Manufacturing design and process understanding.
* Good working knowledge of Solidworks and/or Pro Engineer CAD.
* Strong technical writer.
* Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745.
* Team player with ability to develop strong working relationships.
* Strong communication and interpersonal skills.
* Good problem solving skills.
* Highly motivated individual, self-starter with a passion for excellence.
* Must be able to work in a fast paced environment.
* Willingness and availability to travel on company business.
For more information please forward your CV in the strictest confidence to the link provided.
Skills
R&D, Design, Medical Device, ISO13485
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