Test Method Development Engineer
CREGG are seeking to hire a Test Method Development Engineer to join a dynamic team at a leading company based in Shannon, Co Clare. Reporting to the R&D Manager, you will be part of an expanding team that plays a key role in
Performing R&D Testing, development of tests, Test method validation, execute mechanical performance testing, functional testing, and validation testing of products, to ensure that the products meet regulatory standards and liaise with team on results and findings while improving processes, ensuring compliance with industry standards, and driving continuous improvements.

EXPERIENCE IN LABORATORY PRACTICES, LAB MANAGEMENT PREFERRED.

• Test method development / execution / validation experience desirable
• Medical device / Bio material / Pharma experience advantageous
• Good organizational skills.
• Good attention to detail.
• Excellent verbal and written communication skills.
• Appropriate computer skills.

• Conduct and develop rigorous testing procedures - performance testing, functional testing, and validation testing of products.
• Collaborate with cross-functional teams to understand testing requirements and specifications for new products. Manage multiple testing projects ensuring completion within project timelines.
• Responsible for designing, developing and executing test plans and writing protocols to evaluate the performance and functionality of products simulating real-world clinical situations.
• Design and develop test fixtures and equipment to ensure accurate and efficient testing of the products.
• Create detailed documentation and specifications for test fixtures, including assembly instructions, operating procedures, and maintenance guidelines.
• Collaborate with suppliers and vendors to source and procure necessary components and materials for test fixtures.
• Execute testing on prototypes and final products. Document test procedures, results, and findings, and communicate them effectively to stakeholders, including product development teams, clients and regulatory authorities. Ensure traceability throughout and compliance within the QMS.
• Analyse test results using statistical methods to draw meaningful conclusions to support development decisions. Undertake Root Cause Analysis on failures to identify corrective actions.
• identify any issues or defects, and propose solutions or improvements to enhance the device’s/component’s/Material’s performance.
• Participate in risk analysis and validation activities to ensure that products meet safety and quality standards.
• Requires attention to detail, critical thinking, problem-solving skills, and the ability to work effectively in a team-oriented environment.
• Support testing requirements of BMI partners as required.
• Provide design services to BMI Partners as required, e.g., PBCI.