The R and D Engineer will design, develop, modify and evaluate medical devices in accordance with relevant FDA/BSI and ISO standards. Analyze catheter architecture and related mechanical designs and design requirements. 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. 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.
Qualified to degree level in engineering, science or related discipline. Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.). Knowledge of catheter manufacturing processes (bonding, moulding, etc.) is essential. Experience in bringing a product from concept/design phase to commercial manufacturing. Understanding/working knowledge of relevant FDA/BSI standards and regulatory requirements. Significant experience with design control and ISO13485.