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 (KOL's), 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 responsibly.
Qualifications and Experience:
Third level degree in Mechanical, Biomedical, Science, Design or similar discipline.
3+ years' design experience in medical device roles.
Third level degree in Mechanical, Biomedical, Science, Design or similar discipline.
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 (ISO***** and FDA CFR 820), EU Medical Device Regulation ********.
Team Player with ability to develop strong working relationships.
Strong communication and inter-personal 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.