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Product Development Engineer
2 months ago
Looking for a Medical Device Product Development Engineer for a leading pharmaceutical/medical device company
Location: Cambridge
Duration: 12 months contract
Hourly Rate: £21.84 to 27.95 on Umbrella (Depending upon experience)
Summary
Capable mechanical or product development engineer to support 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 role requires a combination of technical and planning skills to predict (and mitigate) product risks. You will provide project technical support to identify and resolve product issues whilst balancing the needs of other internal Client groups.
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 Client internal design reviews
• Create documentation to support medical device development and industrialization
• Interact effectively with suppliers and other Client groups
Capabilities and Knowledge
Essential
• CAD (preferably Pro-Engineer / Creo) and associated document management systems
• Engineering calculations eg. 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 trouble-shooting
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
• Experience within the medical device industry would be a benefit
