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Medical Device Testing Expert

2 weeks ago

Galway, Galway, Ireland TN Ireland Full time
About Us

TN Ireland is a global medical technology company based in Dublin, Ireland.

Company Overview:

We are seeking a highly skilled Product Development Verification and Validation Engineer to join our team and contribute to the development of innovative medical devices.

Responsibilities:

  1. Test Protocol Development:
    • Develop comprehensive test protocols for various testing domains, including electronic circuit design verification, mechanical design verification testing, and sound stimulation functional testing.
    • Collaborate with design and development teams to ensure that test protocols are aligned with design requirements, manufacturing requirements, and applicable regulatory requirements.
  2. Test Execution:
    • Participate in bench testing (design verification testing) of medical device products based on the developed protocols, ensuring rigorous and thorough execution.
    • Oversee third-party or internal team testing activities, ensuring adherence to protocols and the integrity of the test results.
    • Analyze test results, including the application of statistical methods where appropriate.
    • Document the test results, ensuring accurate record-keeping and comprehensive traceability.
  3. Design & Development Support:
    • Contribute to the design change control process, ensuring that any changes made to the product design are verified, validated, and meet the requirements of applicable procedures and regulations.
    • Collaborate with design and development teams, providing feedback and guidance based on testing outcomes to refine the design.
    • Engage in risk analysis activities, identifying potential design and usage risks, and ensuring they are adequately assessed, controlled, and reported.
    • Assist with document control, ensuring that all design, test, and validation documentation is properly maintained, updated, and compliant with applicable QMS procedures.
  4. Manufacturing Equipment Development & Validation:
    • Participate in the design, development, and validation of manufacturing equipment, focusing on printed-circuit board test fixtures.
    • Collaborate with manufacturing and quality assurance teams to ensure that equipment meets both production and regulatory requirements.
    • Validate manufacturing equipment and tools, ensuring they are fit for purpose and meet the defined specifications.
  5. Continuous Improvement, Training and Collaboration:
    • Maintain up-to-date knowledge of the latest industry standards, regulations, and best practices related to verification and validation.
    • Provide training to junior team members or cross-functional teams on best practices in design validation and verification.
    • Continuously seek opportunities to improve testing methodologies, tools, and processes.
    • Work closely with other departments, including design, manufacturing, regulatory affairs, and quality assurance, ensuring alignment of goals and seamless communication.
    • Present test findings to relevant stakeholders, ensuring clarity of results, inferences, and conclusions of the results and their associated implications to the product development process.