I head the Manufacturing &Technologies division and we focus on products that have been designed and manufactured across a breadth of engineering industries. The division covers a range of markets including CEM’s, electronics, automotive, aerospace, rail, avionics, defence, manufacturing, medical, pharmaceutical, semiconductor and machinery & automation.
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We are looking for a Capable mechanical engineer needed to provide engineering analysis and design support in the medical sector. Working as part of a friendly and well-motivated team managing the development of drug delivery devices, the role may include tasks from all stages of device development from user requirement capture through analysis, testing, validation, manufacture and complaints investigations.
Job DescriptionMechanical project Engineer - Industrialisation
£35,000 - £45,000
A key focus will be on the implementation and transfer-to-manufacture of device designs, including design for assembly and manufacture, specifying assembly and automated test equipment and developing acceptance and batch release testing. Although the tasks may be wide-ranging, they need a combination of technical and planning skills to predict (and mitigate) design engineering risks. The role requires interaction with suppliers and may require occasional travel. It is based near Cambridge, UK.
" Project engineer responsible for the delivery of an effective, documented, manufacturable design
" Produce and approve requirement specifications for devices and equipment for external suppliers
" Produce and interrogate 3D CAD models
" Assess supplier specifications, analyses and test results in the light of design functionality
" Perform tolerance analysis of designs to assess critical functions
" Apply theoretical engineering knowledge (e.g. forces, friction, mechanism analysis, materials) to develop, analyse and critique design concepts and solutions
" Perform Engineering testing (laboratory-based work) to evaluate design proposals and establish functional performance characteristics and investigate problems
" Design test rigs and challenge parts
" Support equipment IQ, OQ, PQ, including test plans, acceptance tests and challenge parts
" Contribute to DFMEA and PFMEA. Communicate potential design risks for wider evaluation by the project team
" Support design reviews, both internal and with suppliers
" Create documentation to support medical device development and industrialization
" Interact effectively with suppliers and other groups
Capabilities and Knowledge
" Experience using CAD (preferably Pro-Engineer/Creo)
" Tolerance analysis using RSS methodology
" Experience of using risk assessment tools including FMEA
" Experience of equipment specification and qualification
" Experience of plastic part design
" Management and prioritisation of own and project tasks
" Trouble-shooting mechanical issues
" Excellent communication skills with other disciplines, including writing clear reports, documents and presentations
" Experience of supplier management
" Understanding of quality management systems including GAMP
" Experience with automated assembly equipment
" Management of suppliers for bespoke products
" Knowledge of injection moulding
" Hand calculations of stress
" Knowledge of ISO13485
" Interpretation of FEA
Education and Experience
" Degree in Mechanical Engineering or equivalent
" A minimum of 2 years' relevant experience
" Experience within the medical device industry would be a benefit
" Experience of manufacturing within a semi- or fully-automated environment would be an advantage
" Practical, analytical, pragmatic, pro-active
" Capable of both working in a team and leading own independent work through to a conclusion
" Communicates well with internal and external team members. Articulates ideas and concepts clearly to all levels and technical abilities
" Able to learn and understand new concepts quickly
" Capable of seeing the wider implications of technical decisions
For someone with a lower level of skill and experience, requiring additional training and development, this would be considered.
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