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.

• 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.