Mechanical Engineer

Zoek Pin Cambridge, Cambridgeshire, England

Permanent (Full time)

Posted 16 days ago

I am delighted to work with an exciting and successful Pharmaceutical company. That is an award winning specialist company in their field. My client offers the pursuit of technical innovation for world class products, whilst being able to gain new skills and grow your career.

RESPONSIBILITIES

Capable mechanical or product development engineer needed for project technical lead in the medical sector. Working as part of a friendly and motivated team leading the development of drug delivery 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 role requires a combination of technical and planning skills to predict (and mitigate) product risks. You will need to demonstrate an ability to understand the patient and the device whilst balancing project and business requirements. The role may require occasional travel.

Role Functions
• Support the design and development of drug delivery devices
• Produce models and drawings using 3D CAD
o Modify and develop 3D CAD & drawings from non-native CAD systems
• Produce and approve requirement specifications for external suppliers (UK and abroad)
• Analyse supplier designs to identify areas critical to function, likely failure modes and design sensitivities.
• Identify, analyse and communicate user needs
• Perform tolerance analysis using RSS or Montecarlo methodology
• Design test rigs and challenge parts
• Perform Engineering testing (laboratory-based) to evaluate design proposals and establish functional performance characteristics
• Analyse test results to determine design performance and acceptability
• Risk management assessment and mitigation, including DFMEA and input to UFMEA.
• Support supplier design reviews and internal design reviews
• Balance technical requirements with user preference data
• Support Design for Manufacture and Design for Assembly discussions with internal and external design teams
• Create documentation to support medical device development and industrialization
• Interact effectively with suppliers and other groups

Capabilities and Knowledge
Essential
• CAD (preferably Pro-Engineer / Creo) and associated document management systems
• Engineering calculations eg friction, beam bending
• Experience of using risk assessment tools including FMEA
• Experience of design with plastic components
• Management and prioritisation of project tasks
• Writing clear reports, documents and presentations
• Understanding of quality management systems
• Good understanding of complex mechanical systems

Desirable
• Knowledge of ISO13485
• Experience of user-centred design
• Experience of electro-mechanical systems
• Management of others’ tasks, including managing suppliers
• Knowledge of injection moulding.
• Experience of FEA
• Knowledge of Solidworks

Education and Experience
• Degree in Mechanical Engineering or equivalent
• Experience within the medical device industry would be a benefit

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