Research and Development Manager

Research and Development Manager

Cook Medical

Limerick, Ireland

Overview

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

Reporting to: Research & Development Program Manager/Director of Research & Development.

Responsibilities

  • 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;
  • 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, 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.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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