• Research and Development Manager

    Requisition ID
    2019-6971
    Job Location(s)
    Limerick Ireland
    Company
    Cook Ireland
    Position Type
    Full Time
    Category
    Engineering
  • Overview

    Manage the relevant Product Development Team/Teams, develop product pipeline and bring to market medical devices.

     

    Reporting to: Director of Engineering  

     

     

    Find out more about Cook Medical here

    Responsibilities

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

    Qualifications

    • 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 (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.

     

     

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