We are looking to invest in an enthusiastic, skilled, and innovative Design Engineer who thrives to deliver market leading technology which is appealing to end users. As part of the R&D department you will be working 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.
This role is to join a team of multi-disciplinary engineers. Design Engineers will be working on multiple projects, researching / developing new technologies and applications, and engineering a wide range of devices for pharmaceutical customers, Owen Mumford product lines and life cycle management of on market devices.
There are four teams within R&D: Technology development, Product design, Design engineering, and Continuous improvement. The skills required and responsibilities assigned vary from one team to another, as such the skills and responsibilities detailed below are discretionary.
Design Engineers from all groups responsibilities include, but are not limited to:-
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. Assist project delivery by identifying tasks, and assisting with creation of project plans and independently controlling design projects / sub-projects.
Customer Interaction: Will be required to lead customers throughout projects in a professional manner. Interactions may involve project updates, providing support for engineering changes, collaborating to create product design specifications and user requirement documents
Mechanical Design: Developing and engineering features, components, and assemblies in 3D CAD (SolidWorks). Providing robust and innovative solutions to improve product range. Developing and supporting intellectual property portfolio where appropriate. Will be required to assess and select appropriate 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.
Technical Report Writing: Create well reasoned and thorough technical reports to support engineering analysis, design decisions, test data, research, design verification, and technical investigations. Provide peer review of reports created by other team members. Assist in generation of test protocols and reports.
Product Design: Establish and develop understanding of market, user, and pharmaceutical customer needs. Perform all product design cycle activities such as attending user studies / focus groups, identifying opportunities, establishing 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. Perform changes required to meet requirements recommended by the HFE process. Provide all necessary information and materials required to perform formative and summative studies, and to create HFE background documents.
Design Analysis: 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).
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). 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.
Support development of Junior Design Engineers.
Knowledge and Expertise
Minimum of 2 years in a design engineering (or similar) role within a medical or similarly regulated environment.
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.
Proficient CAD user (SolidWorks). 3D, 2D, Surfacing
Highly computer literate eg Excel/Word and PowerPoint
Risk assessment (such as FMEA)
Ability to produce technical reports
Materials knowledge (Plastics)
Technical drawing, geometric tolerancing, and tolerance analysis
Good understanding of prototyping techniques.
Design for manufacture (tooling and assembly)
Experience of quality management systems
Design change control
Experience within Medical Device or similar regulated industry. E.g. ISO 13485, FDA 820.30.
CAE/FEA Design analysis (Abaqus)
Human factors engineering
Hours of work - Monday - Friday, 37.5 hours per week (flexi-time)