Main Purpose of Job Responsible for creating and generating innovative designs for all new company products and developing internal design management systems for continuous improvement. Supporting the wider new product development process. Managing the administration of documentation (DHF) for new product development and existing product development. Main Tasks/Responsibilities Determine design requirements by consulting with product managers, Head of Design and Company directors, before conducting design work. Research and investigate user needs and target market for new products during initial project phases. Produce innovative conceptual designs using sketch work and Computer Aided design. Ensure key sign off milestones and reviews are followed and documents during the product development process. Liaise with suppliers to gain a full understanding of technical and commercial feasibility for the product being developed. Liaising with suppliers to gain technical documentation Preparation of and completing requirement specification documents for existing and new products, and other related documents to assist product managers. Liaise with the Regulatory team to establish relevant regulatory standards for the product being designed. Read and interpret key standards that the product must conform to. Ensure compliance of the product design according to regulatory standards. Project managing the “change control” process to ensure new product development documentation is available, signed off and filed Management of prototyping and testing requirements on new product design projects. Design mechanical rigs to test and evaluate development prototypes. Design and develop new packaging solutions. Management and preparation of design history files to meet ISO 13485 compliance and supplement regulatory Technical Files for annual ISO 13485 audit purposes. Pro-active organization of regular internal design meetings and reviews at key phase stage gates. Creation of high quality CAD models and 2D detailed technical drawings to industry standard. Carry out updates to existing design as and when required according to formal change requests. Completion of other reasonable tasks that may be asked by Company Directors. Knowledge & Qualifications Essential 3 years product design experience Degree or equivalent certification in product design, industrial design or relevant design engineering discipline. Substantial experience in the management and completion of product design projects. Substantial experience in the use of SolidWorks 3D CAD software. (Or other 3D CAD software) Understand the specific regulatory requirements for medical devices and be able to translate these into product design. Understanding of producing 2D technical drawings to BS8888. Substantial experience of designing parts for plastic injection moulding (DFM). Desirable Experience in the design of medical devices Experience within the medical devices sector (2 or more years’ experience). Understanding of ISO13485. Extensive knowledge of a variety of manufacturing processes. Project Management experience. Build extensive knowledge of GBUK product ranges and common issues. Knowledge and experience of intellectual property (IP). Experience of Usability Engineering. Experience in packaging Design Skills/Competencies Capable of working in a team and independently. Problem Solver Able to project manage multiple tasks Good communication skills Organised working style. Eye for detail. High level of computer literacy NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organisation.