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Mechanical Design Engineer

2 months ago


Aberdare, Rhondda Cynon Taf, United Kingdom Hunter Selection Full time

Job Summary:

Hunter Selection is seeking a skilled Mechanical Design Engineer to join our client's team in Aberdare, Rhondda Cynon Taff. As a key member of the organization, you will be responsible for designing and developing medical devices from concept to market release.

Key Responsibilities:

  • Design and develop medical devices, ensuring compliance with regulatory requirements such as ISO13485:2003/MED DEV 93/42/EEC and FDA regulations.
  • Compile Design History Files (DHF) and ensure accurate documentation of product design, specifications, and testing.
  • Lead project actions in the UK and manufacturer, ensuring smooth design transfer and implementation.
  • Provide engineering requirements for Engineering Change Orders (ECOs) and maintain allocated legacy DHFs.
  • Verify and validate components and assemblies, ensuring compliance with design standards.
  • Record all formal and relevant engineering information in the Product Life-Cycle Management System.
  • Modify and amend new and existing drawings in accordance with design standards.

Requirements:

  • Proven experience in product design and development, with a focus on medical devices.
  • Strong understanding of regulatory requirements, including ISO13485:2003/MED DEV 93/42/EEC and FDA regulations.
  • Experience working with Product Life-Cycle Management Systems and/or ERP Systems.
  • Excellent problem-solving skills, with the ability to apply techniques such as DFMEA and Risk Analysis.
  • Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.

What We Offer:

  • A competitive salary of £40,000 per annum, plus excellent training and development opportunities.
  • A stable and secure work environment, with opportunities for career growth and progression.
  • A collaborative and dynamic team environment, with a focus on innovation and excellence.