Senior Design Engineer - Product Introduction & Continuous Improvement

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As the Senior Design Engineer you will join the R&D department to work on exciting and challenging projects from conception through to production. You will have the opportunity to experience all aspects of a full medical device design role working alongside Customers, Sales and Marketing, Project Management, Quality, and Manufacturing departments.

Reporting directly to a Principal Design Engineer & Design Team leader you will be an integral member of the R&D Team and accountable for leading design projects and tasks within New Product Introduction and Continuous Improvement (NPICI), focussed on ensuring that projects are robustly developed in line with the specific goals of the relevant phase from Research to on Market and scaling.

• Project Work:
  Delivering project tasks in a timely manner to a high standard with minimal support. Interacting and communicating effectively within project teams in both support, and design lead roles. Demonstrate experience of project delivery by identifying tasks and assisting with creation of project plans and independently controlling design projects / sub-projects. Required to share concepts and design intent across functions and customers with excellent presentation skills.
• Customer Interaction:
  Will be required to lead technical discussions with customers in a professional manner. Interactions may involve project updates, providing support for engineering changes, collaborating to create product design specifications and user requirement documents. Able to offer guidance and improve customer confidence through prior experience.
• Mechanical Design:
  Develop and refine features, components, and assemblies in 3D CAD (Solid Works). Provide robust and innovative solutions to improve product range. Developing and supporting intellectual property portfolio where appropriate. Provide support and guidance to design engineers and junior design engineers. Expected to have a high level of competence in all CAD aspects. Apply a broad knowledge of material properties in the selection of materials.
• Manufacturing Engineering:
  Generating new and revised 2D detailed engineering drawings to a high standard with consideration given to manufacturing tolerances, measurement, and controlling design intent. Liaising with industrialisation teams to optimise design for manufacture and assembly. Apply knowledge of existing processes at an early stage in the design process to streamline industrialisation phases.
• Product Design:
  Establish and develop understanding of market, user, and pharmaceutical customer needs. Responsible for all product design cycle activities. Assist in organisation and preparation of materials for user studies / focus groups. Identify product / feature opportunities and evaluate contributions from team. Lead the creation of design input documents, concept generation, and development.
• Human Factors Engineering:
  Work alongside Human Factors Specialist with resources available to ensure products are safe in use, intuitive, and effective. Ensure user centred focus is applied to products under development. Responsible for ensuring all designs meet requirements recommended by the HFE process. Ensure all necessary information and materials required to perform formative and summative studies, and to create HFE background documents are provided by design team.
• Design Analysis:
  Identify analysis requirements. Review, justify and perform analysis of design integrity through analytical methods and laboratory testing. Mitigate, and optimise through the use and application of a range of tools such as FMEA, Tolerance analysis, and FEA (Abaqus). Expected to bring a high level of experience to design analysis from past projects, issues, and resolutions.
• Regulatory:
  Establish, demonstrate, and apply an understanding of appropriate regulatory frameworks throughout product development. All work to be carried out to GMP (Good Manufacturing Processes). Lead generation of design control documentation such as design and development plan, design input / output documents, design verification, design validation, design transfer, design review, design history file, and design change documents.

• Minimum of 6 years in a design engineering (or similar) role within a medical or similarly regulated environment.
• Experienced in leading design projects.
• Mechanical design and development of plastic parts for injection moulding. Full understanding of tooling requirements and features.
• Able to create, understand, and develop complex features, components, and assemblies.
• Proven ability to solve technical problems.
• Experience with in Medical Device or similar regulated industry.
  
  E.g. ISO 13485, FDA 820.30.
• Proficient CAD user (Solid Works). 3D, 2D, Surfacing
• Highly computer literate e.g. Excel/Word and Power Point
• Risk assessment (FMEA)
• Ability to produce technical reports
• Experience of quality management systems
• Materials knowledge…