Senior Design Engineer - Development

Overview

Owen Mumford are looking to hire an enthusiastic Senior Design Engineer. This role is a Fixed Term Contract (6-12 months). You will join the R&D department to work on exciting and challenging projects from conception through to production, experiencing all aspects of a full medical device design role 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 lead design projects and tasks within Device Development, focused on ensuring that projects are robustly developed in line with the 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 project delivery by identifying tasks and assisting with creation of project plans and independently controlling design projects / sub-projects. Share concepts and design intent across functions and customers with excellent presentation skills.
• Customer Interaction:
  Lead technical discussions with customers in a professional manner. Interactions may involve project updates, supporting engineering changes, collaborating to create product design specifications and user requirement documents. Provide 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. Develop and support intellectual property portfolio where appropriate. Provide support and guidance to design engineers and junior design engineers. Maintain high competence across CAD aspects. Apply knowledge of material properties in material selection.
• Manufacturing Engineering:
  Generate new and revised 2D detailed engineering drawings with consideration of manufacturing tolerances, measurement, and design intent. Liaise with industrialisation teams to optimise design for manufacture and assembly. Apply knowledge of existing processes early to streamline industrialisation phases.
• Product Design:
  Understand 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 the team. Lead the creation of design input documents, concept generation, and development.
• Human Factors Engineering:
  Work with the Human Factors Specialist to ensure products are safe in use, intuitive, and effective. Apply user-centred focus to products under development. Ensure designs meet HFE requirements and provide necessary information and materials for formative and summative studies and HFE background documents.
• 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 of tools such as FMEA, Tolerance analysis, and FEA (Abaqus). Bring a high level of experience to design analysis from past projects, issues, and resolutions.
• Regulatory:
  Understand and apply appropriate regulatory frameworks throughout product development. All work to GMP. Lead generation of design control documentation including design and development plan, design input/output documents, design verification, design validation, design transfer, design review, design history file, and design change documents.

• Strong experience 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.
• Experie…