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Ruth Holland
Life Science

01 507 9255
[email protected]
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R&D Manager

Reference:/RH/AFBB-033163 Location: Limerick
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

R&D Manager 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:

  • Perform Duties of Research and Development Manager:
    • In conjunction with the Director of Engineering develop strategic vision and product pipeline strategy for designated area.
    • Implement above strategy/vision.
    • Liaise with internally and external teams to develop R&D function.
    • Identify appropriate research opportunities and work with internal teams, University/College research teams or third party contractors to research and develop clinical product solutions.
    • Maintain and improve high standard of medical device engineering.
    • Technical responsibility for all products and projects with assigned group.
    • Implement and maintain high standards of design control.
    • Identify new technologies, source new materials, components and equipment as required to develop capabilities within their designated areas.
    • Identifying new vendors and strategic partners for product development and component/subassembly supply.
    • Manage the development of the IP portfolio for their area of responsibility.
    • Actively engage with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
    • Manage R&D Projects for other SBU’s as required.
  • Team Management:
    • Lead the Product Development team/s allocated to them.
    • Ensure team/teams deliver quality designs in a timely manner.
    • Mentoring, coaching and development of direct reports to attain best performance.
    • Perform routine appraisals to deliver best results and to obtain the maximum team performance.
    • Foster innovation and creativity within team and perform disclosure reviews.
    • Manage the activities of the product development team and hold regular team meetings.
    • Ensure R&D KPI’s and business metrics are achieved.
  • Quality, Regulatory and Business Systems:
    • Manage Quality Systems compliance within designated teams/group.
    • Review and approve quality system documentation to required QSP/SOP’s and standards.
    • Actively develop and contribute to the development of the Quality systems.
    • Ensure compliance with quality and regulatory requirements (ISO 13485 and FDA CFR 820) in bringing new products to the market.
    • Monitor product complaints and manage appropriate actions.
    • Ensure all Business is conducted in an ethical manner.
  • Act as a designee for the Director of Engineering and the Engineering Laboratory Manager and the Senior Test Engineer for change control review as per Quality System Procedures.
  • Develop and maintain strong working relationships with the senior SBU and product management leaders in their designated areas. Appropriate travel to achieve this goal.
  • Regular communication to local and external management.
  • Manage other projects as assigned by Director of Engineering.

Education and Experience:
  • Third level degree in Mechanical, Biomedical, Design, Chemical engineering/science or similar discipline.
  • 7 years design experience with at least 3-4 years gained in senior medical device roles.
  • Must have demonstrated vision and proven strategic ability to deliver and achieve this vision.
  • Proven Team Leadership abilities.
  • Good Project Management methodology and skills.
  • Must have demonstrated ability to develop core technology/product designs from concepts through to commercialisation.
  • Proven track record in delivering quality results in a timely effective manner.
  • Strong knowledge of Endoscopy & Peripheral Intervention business.
  • Good mechanical design, materials aptitude and understanding of engineering fundamentals with extensive medical device materials knowledge.
  • Innovative/Creative Engineer.
  • Good manufacturing design and process understanding.
  • Strong communication and inter-personal skills.
  • Good presentation skills (working knowledge of MS PowerPoint).
  • Strong technical writer.
  • Must have good understanding of IP process.
  • Good working knowledge of medical device quality & regulatory systems and medical device directives, EU Medical Device Regulation 2017/745, (ISO13485 and FDA CFR 820).
  • Team Player with ability to develop strong working relationships.
  • 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 contact Ruth Holland on 087 7822 198 or [email protected]