Product Development Engineer

4 weeks ago

Cambridge Cambridgeshire, United Kingdom Russell Tobin Full time

Looking for a Medical Device Product Development Engineer for a leading pharmaceutical/medical device company Location: Duration: 12 months contract
Hourly Rate: £21.95 on Umbrella (Depending upon experience)

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.

Support the design and development of drug delivery devices
• Risk management assessment and mitigation, including DFMEA, input to UFMEA and assessment of critical functions.
• 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
• 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
• Create documentation to support medical device development and industrialization
• CAD (preferably Pro-Engineer / Creo) and associated document management systems
• Engineering calculations eg. 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
• Experience of electro-mechanical systems
• Experience of design with plastic components
• Knowledge of injection moulding.
• Knowledge of Solidworks

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

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