Research and Development Engineer
My client is hiring an R&D Engineer to join their team. This is a wonderful opportunity to work on all aspect of the Design Life Cycle, offering amazing exposure and experience. As an R&D Engineer will design, develop, modify and evaluate medical devices. The engineer will use structured engineering, problem solving and statistical techniques to design and develop new products and/or improve existing products whilst adhering to regulatory requirements, project deadlines and budgets.
Primary Roles & Responsibilities
- Design and set-up experiments, manage evaluation testing and work with suppliers/manufacturers in developing new and existing products
- Actively involved in specifying, sourcing, testing and approving material
- Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents
- Project manage transfer of products from concept/design phase to commercial manufacturing
- Follow design control procedure/standards in accordance with ISO13485
- Create and maintain design-related technical notes (notebooks, protocols, validations, manufacturing documents, etc.) building a complete design history file
- Compile and analyse operational, test and development data to establish performance standards for newly designed or modified products
- Manage and prepare engineering test protocols and reports
- Provide new design concepts
- Work with relevant functions in transferring R&D projects to commercial operations.
Skills & Qualifications
- Qualified to degree level in engineering, science or related discipline
- Medical device development experience essential
- Experience with catheter systems preferable
- Strong mechanical design skills
- Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.)
- Knowledge of catheter manufacturing processes (bonding, moulding, etc.)
- Experience in bringing a product from concept/design phase to commercial manufacturing
- Understanding/working knowledge of relevant standards and regulatory requirements
- Strong project management, organisation, computer and leadership skills essential
- Experience in risk assessment and FMEA
- Six sigma green belt experience preferable
- Good working knowledge in statistical process control and capability analysis using DMAIC and DOE techniques
- CAD experience preferable
- Influential team member, fully motivated to achieve and demonstrate best practices in line with the department company objectives
Excellent Salary & Benefits.
For a confidential discussion and more information on this role, please contact Nicola Walsh.