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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Senior R&D Engineer


Reference:/RH/AFDS-702841 Location: Limerick City
Qualification:DiplomaExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Research and Development, Research and Development Engineer

Senior R&D Engineer required for a staff role with a Limerick based Medical Device facility.


Role Summary:

Work as part of a Research & Development team in the design and process development of medical devices to take to market for the MedSurg Division.


Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Design and process development:
  • Prototyping and test method design.
  • Design and process evaluation, reviews, specifications, verification and validation, protocols and reports and transfer to production activities in a timely and effective manner.
    • Product and project risk analysis and risk management.
    • Develop prototypes which are consistent with the clinical and design requirements of the project.
    • Research new therapies and design solutions to develop and complement the existing product portfolio.
    • Introduce new equipment, materials and technologies.
    • Generation of Design History File documentation.
    • Support of regulatory submissions.
  • 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 team/s including technical and project management leadership responsibly, if required.
    • Lead technical development of projects.
    • Lead key design decisions to ensure quality design selection.
    • Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
    • Work closely to build effective relationships with cross functional groups to achieve project and company goals.
    • Retrospective project reviews to understand lessons learned.
    • Manage device evaluations.
    • Compliance with Quality, Regulatory and company policies and systems


Education and Experience:
  • Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
  • 7+ years’ experience.
  • Proven Project Leadership abilities.
  • Experience in DOE and/or Gage R&R is preferred.
  • Strong statistical understanding and experience, including good working knowledge of Excel and/or Minitab.
  • Good Project Management methodology and skills.
  • Proven track record in delivering quality results in a timely effective manner.
  • Knowledge of anatomy and physiology.
  • Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Innovative/Creative Engineer.
  • Good manufacturing design and process understanding.
  • Good working knowledge of Solidworks and/or Pro Engineer CAD. Good presentation skills (working knowledge of MS PowerPoint).
  • Strong technical writer.
  • Attention to detail and Quality focus.
  • Good working knowledge of medical device quality & regulatory systems and medical device directives, EU Medical Device Regulation 2017/745, (ISO13485 and FDA CFR 820).

For more information contactRuth Hollandon087 7822 198or[email protected]