is proud to be supporting a Medical Device business who design, develop, manufacture and distribute a broad range of products/devices globally. An exciting opportunity has arisen to join the Team as a
Product Designer
and this role will suit someone with an Industrial Design/Product Design background. A well-rounded designer who can innovate, problem solve, take things from a blank sheet of paper, conceptualise them and then engineer product with a sound understanding of manufacturing processes. You will be involved in creating and generating innovative designs for all new company products, supporting the wider new product development process. Managing the administration of documentation (DHF) for new product development and existing product development. Responsibilities:
Determining design requirements through consultation with product managers, Design Head, and Company Directors, before progressing design work. Researching and investigating user needs and target market for new products during initial project phases. Producing innovative conceptual designs using sketch work and Computer Aided design. Ensuring key sign-off milestones and reviews are followed along with documentation during the product development process. Liaising with suppliers to gain a full understanding of technical/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. Liaising with the Regulatory team to establish relevant regulatory standards for the products 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 ISO13485 compliance. 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. Carrying out updates to existing design as and when required according to formal change requests. Knowledge & Qualifications
Essential
Degree or equivalent certification in product design, industrial design or relevant design engineering discipline. 3 years Product Design Experience. 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. Understanding of ISO13485. Extensive knowledge of a variety of manufacturing processes. Project Management experience. Knowledge and experience of intellectual property (IP). Experience of Usability Engineering. Experience in packaging Design.
#J-18808-Ljbffr