Would you like to join a well-known medical device company in Limerick, to further develop your career in R&D, and ensure the development of life saving products for physicians and patients worldwide? In this role, you will manage the relevant Product Development Team/Teams, develop product pipeline and bring to market medical devices. You will report to the Director of Engineering.
• 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.
• 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.
• 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.
Qualification & 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.
• 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.
• Good mechanical design, materials aptitude and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255