R&D Engineer required for a staff role with a Limerick based Medical Device facility.
Essential Duties and Responsibilities may include, but are not limited to, the following:
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.
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.
Manage and drive project tasks to ensure timely completion of project milestones.
Work closely with cross functional groups to achieve project and company goals.
Product performance evaluations.
Contribute to innovation and creativity within team through filing of disclosures and patents.
Hold regular project meetings and document minutes and actions.
Ensure project milestones are achieved to meet business metrics.
Education and Experience:
Third level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
2 Years design experience 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.
For more information contactRuth Hollandon087 7822 email@example.com