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.
