This innovative medical device organisation is seeking a Senior R&D Engineer to join their growing team. This is an organisation that continues to grow its footprint in Waterford and provides tangible career opportunities.

The Position:

• Product/device development at all phases (idea generation through to commercialisation)
• Generation and testing of prototypes and sample products
• Material development
• Manufacturing and process development
• Carry out Design & Development procedures, FMEcA, Risk analysis etc.
• Follow project plans in line with company objectives
• Liaison with Universities, Institutes, suppliers and commercial organisations when required
• Work to achieve goals and objectives as defined in R&D project plans
• Support operations to source and validate suppliers and ensure necessary materials are available when required for the R&D programme and manufacturing
• Liaise with appointed Quality and regulatory affairs coordinator
• Monitor regulatory issues relating to medical devices under development
• Patents: searching and preparation of patent drafts with validated information and specifications
• Ensure that product development is compliant with the company's regulatory and quality systems, procedures, documentation, audits, and compliance for CE marking etc.
• Generation and control of documentation for design history and technical files etc.
• Desktop research
• Testing and characterisation of materials
• Biomechanics testing of lower extremity products including gait and plantar foot pressure mapping
• Support Manufacturing team and design transfers to production

The Person:

• 2-5 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.