Research and Development Manager
OverviewManage the relevant Product Development Team/Teams, develop product pipeline and bring to market medical devices.
You will be reporting to the Director of Engineering and have 8 Direct Reports.
- 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.
- 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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