Medical Device Design Professional

11 hours ago

Cork, Cork, Ireland beBeeDesign Full time €50,000 - €75,000

Medical Device Design Expertise Required

A medical device company is seeking an experienced design engineer to join their professional core team with exposure across engineering & commercial functions. This role offers a unique opportunity to work on the development of novel medical devices for the global market.

Key Responsibilities:

  • Translate customer and patient information into user needs, driving innovation in medical device design.
  • Develop concepts (CAD) and prototypes (3D print) of novel medical devices, leveraging expertise in product design and development.
  • Contribute to design reviews, providing valuable insights and suggestions to optimize product performance and manufacturability.
  • Support manufacturing of new products with tooling, product design, and process validation, ensuring seamless production processes.
  • Analyze data sets using statistical techniques, generating reports summarizing information and driving data-driven decisions.
  • Responsible for on-site laboratory testing, managing off-site testing labs and test houses required for external testing, ensuring compliance with regulatory standards.
  • Execute design controls activities per FDA 21 CFR Part 820: design verification, design validation, and design transfer, maintaining regulatory compliance.
  • Generate design verification/validation protocols and reports; conduct risk management activities per ISO 14971, prioritizing patient safety.
  • Responsible for creation of quality system and regulatory documentation, ensuring accurate and compliant records.

Job Requirements:

  • Bachelor of Science in Engineering, Mechanical Engineering/Biomedical, with 5+ years experience in a medical device company regulated by FDA/EU.
  • 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, with experience in ISO 14971 and IEC 62366, staying up-to-date with industry developments.
  • Generating technical files and regulatory documentation associated with medical devices, demonstrating expertise in document creation.

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