Mechanical Design Engineer required for a globally leading Pharmaceutical company for their site near Cambridge.
The Mechanical Design Engineer will be supporting drug delivery medical devices. The role may include tasks from all stages of device development from user requirement capture and due diligence assessment of vendor activities through to validation, transfer-to-manufacture and complaints investigations. The occupant requires a combination of technical and planning skills to predict (and mitigate) product risks. As well as providing project technical support to identify and resolve product issues whilst balancing the needs of other internal groups.
The Mechanical Design Engineer is available as an initial 12-month contract (Inside IR35). On offer is a competitive rate.
Role Functions
Support the design and development of drug delivery devices
Risk management assessment and mitigation, including DFMEA, input to UFMEA and assessment of critical functions.
Produce and justify requirement specifications for external suppliers
Apply theoretical engineering knowledge (e.g. forces, friction, mechanism analysis, materials) to analyse and critique design concepts and solutions, identifying areas critical to function, likely failure modes and design sensitivities, both by hand and using software tools.
Perform tolerance analysis using RSS or Montecarlo methodology
Design test rigs and challenge parts
Manage early-stage usability studies to capture patient capabilities and preferences
Produce models and drawings using 3D CAD
Perform investigative lab testing to predict design performance and acceptability
Analyse test results to determine design performance and acceptability
Support supplier design reviews and internal design reviews
Create documentation to support medical device development and industrialization
Interact effectively with suppliers and other groups
Capabilities and Knowledge:
Essential
Ideally 3+ years of experience
CAD (preferably Pro-Engineer / Creo) and associated document management systems
Engineering calculations e.g. free body diagrams, friction, beam bending
Good understanding of complex mechanical systems
Experience of using risk assessment tools including FMEA
Management and prioritisation of project tasks
Understanding of quality management systems
Writing clear reports, documents, and presentations
Excellent communication skills with other disciplines
Critical thinking, problem solving and troubleshooting.
Desirable
Knowledge of ISO13485
Experience of user-centred design
Experience of electro-mechanical systems
Experience of design with plastic components
Knowledge of injection moulding.
Experience of FEA
Knowledge of SolidWorks.
Education and Experience
Degree in Mechanical Engineering or equivalent