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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior Mechanical Engineer


Reference:JCAO1505 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Mechanical Engineer, Research and Development Engineer, Senior Research and Development Engineer, Snr R and D Engineer

Senior Mechanical Engineer

Our client a high potential medical device start up currently seeking a Senior Mechanical Engineer to join their team. The Senior Mechanical Engineer will work as part of the R&D team and will be responsible for development of mechanical components of a new medical device across all stages of product life-cycle.


Role/Responsibilities:

  • Lead the design and development process of the mechanical components for a novel medical device, in compliance to internal procedures including EU and FDA requirements from design phase up through to production
  • Support / coordinate supplier selection activities.
  • Developing and delivering project plans to performance, time and cost targets
  • Component/assembly design and preparation of associated drawings and specifications.
  • Lead the development of design and risk management documentation, including Market requirements, Design Specifications, Design Verification and Validation protocols and reports.
  • Conduct design reviews and identify potential design risks and develop appropriate risk mitigation plans.
  • Support preparation of compliance package for product evaluation / certification
  • Support preparation of demos for user studies, company presentations, etc.
  • Support clinical studies involving the use of the developed products
  • Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation
  • Ensure full traceability of Design Development and control of changes.
  • Ensure full and effective transfer of system after Design Freeze to manufacturing areas ensuring that the product and processes are developed to allow product/process verification/validation to begin
  • Train, develop and lead R&D engineers and other technical staff. Assign tasks and provide support and assistance to the development team
  • Provide assistance and support to other departments including Manufacturing, Quality and Regulatory as required
  • Management of budget relating to development of mechanical components
  • Agreement of budget relating to human resources needed for mechanical development
Skills/Experience:

  • Minimum Bachelor’s Degree in Mechanical / Medical / BioMedical Engineering
  • 5+ years previous experience in a Medical Devices environment with extensive knowledge of medical device product development
  • Familiarity with medical device regulations and standards (e.g. ISO 13485, IEC 60601, ISO 14971, etc.)
  • Experience with biocompatibility requirements and standards (e.g. ISO 10993-1)
  • Experience with devices that incorporate fabric / textiles
  • Highly proficient in SolidWorks or similar CAD tools
  • Experience with injection mould design and manufacturing.
  • Experience with volume manufacturing
  • Experience with DFM, DFA, DFT, etc.
  • Analytical approach to problem solving and good attention to detail.

For further information please contact James Cassidy [email protected] or call in confidence 086-0204322