Halian Technology 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 fornewproductsduring initial project phases. Producing innovative conceptual designsusing sketch work and Computer Aided design. Ensuring keysign offmilestones and reviews are followedalong with documentationduring the product development process. Liaising with suppliers to gain a full understanding of technical/commercial feasibility for the productbeing developed. Liaising with suppliers to gaintechnicaldocumentation Preparation of and completingrequirementspecificationdocuments for existing and new products,andother related documents to assist product managers. Liaising withtheRegulatory team to establish relevant regulatory standards for the products being designed. Read and interpret keystandards that the product must conform to. Ensure complianceofthe 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 ofprototyping and testing requirements onnewproduct design projects. Designmechanicalrigs totest andevaluate development prototypes. Design and develop new packaging solutions. Managementandpreparation ofdesign history filesto meetISO13485 compliance Pro-active organizationof regular internaldesign meetings and reviews at key phase stage gates. Creation ofhigh qualityCAD 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 inproductdesign, industrial design orrelevantdesignengineering discipline. 3yearsProduct Design Experience Substantial experience in themanagement and completion of product design projects. Substantial experience in the use of SolidWorks 3D CAD software.(Or other 3D CAD software) Understandthe 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 designingparts for plastic injectionmoulding (DFM). Desirable Experience inthedesign of medical devices Understanding of ISO13485. Extensive knowledge of a variety of manufacturing processes. Project Management experience. Knowledge and experience ofintellectual property(IP). Experience of UsabilityEngineering. Experience in packaging Design ADZN1_UKTJ