The organisation develops intelligent devices providing high quality care for patients throughout the world. At their site based in Waterford, the organisation focuses upon the development of medical devices. Due to expansion at this site, the organisation require an R&D Programme Manager to join their team.
The Position:
- Supervision of R&D department, staff and facilities
- Develop NPD project plans with stakeholders
- Update, maintain and monitor project plans in line with company objectives
- Works to achieve goals and objectives as defined in R&D project plans
- Carry out D&D activities, procedures, FMEcA, Risk analysis etc.
- Material development, testing and characterisation
- Product/device development at all phases (idea generation through to commercialisation)
- Control and preservation of proprietary and third party intellectual property
- Ensure that all intellectual property generated at FastForm is captured, stored, and protected.
- Liaison with Clinicians, Customers, Universities, Institutes, suppliers and commercial organisations when required
- Market research - VOC: Liaise with Clinicians and market stakeholders to generate product user requirements for NPD projects
- Coordinate clinical studies and trials
- Conduct training workshops with clinicians and customers
- Manage and maintain accurately all documentation relating to the R&D Tax credit scheme. Generate detailed status reports and documentation to support submissions for R&D tax credits claims
- Support marketing
- Prepare ongoing progress reports on a monthly basis or as requested
- Liaise with the appointed consultant(s) and person(s) with overall responsibility for quality and regulatory affairs at FastForm Research
- Monitor regulatory issues relating to medical devices under development
- Prepare patent drafts with validated information and specifications
The Person:
- 5 years' experience in an R&D role, working to ISO 13485 standards
- Third level qualification in Mechanical, Industrial design, Manufacturing, Polymer Engineering, Chemistry, Biomedical, Materials Science or related
To learn more about this role apply online or contact Paul Wheatley on +353873449559 for a confidential discussion.
