Medical Device Design Specialist

1 day ago

Cork, Cork, Ireland beBeeDesign Full time €90,000 - €110,000
Design Engineer Medical Device

A medical device design engineer is required to join our client, an award-winning Irish company developing novel medical devices for the global market. This excellent opportunity provides exposure across engineering and commercial functions.

The Role:
  1. Research and translate customer and patient information into user needs.
  2. Develop concepts (CAD) and prototypes (3D print) of novel medical devices.
  3. Contribute to design reviews, offering valuable insights and suggestions to optimise product performance and manufacturability.
  4. Provide support for manufacturing of new products with tooling, product design and process validation.
  5. Analyse data sets using appropriate statistical techniques and generate reports to summarise the information.
  6. Responsible for on-site laboratory testing.
  7. Manage off-site testing labs and test houses required for external testing.
  8. Execute design controls activities (design verification, design validation and design transfer) per FDA 21 CFR Part 820.
  9. Generate design verification/validation protocols and reports.
  10. Conduct risk management activities per ISO 14971.
  11. Responsible for creation of quality system and regulatory documentation, such as user requirements specifications, design inputs and outputs.

Requirements:
  • Bachelor of Science in Engineering, Mechanical Engineering/Biomedical and 5+ years experience working for a medical device company whose products and processes are FDA/EU regulated.
  • Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820, especially design verification and validation.
  • Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.
  • Experience in generating technical files and regulatory documentation associated with medical devices, such as risk analysis, dFMEA, DIOVV and related documents.

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