Our client, a medical device company in Galway are currently looking to recruit Design Assurance Technician a for their site.
Working with the Design Assurance team in a test laboratory environment, being responsible for sample and new product testing, simulated life testing, failure investigations, test data management, report writing and Test Method Validations.
In the absence of the Section Leader Design Assurance, the Design Assurance Technician will report to a Design Assurance Engineer.
- Execute simulated life tests on existing and new nebulizer products and accessories.
- Investigate failures using formal problem-solving techniques.
- Support new test development and appropriate test method validation.
- Maintain and calibrate test equipment.
- Manage test data and write test reports for design history filing or regulatory submissions.
- Conduct software validation on device and supporting software-based systems.
- Supports external audits including notified body and FDA audits.
- A diploma in Electronics, Engineering or Technology
- At least 2-4 years’ experience working in a test laboratory environment with electronics/software based products.
- Excellent planning and coordination skills plus verbal and written communication skills.
- Knowledge of mechanical ventilation and accessories would be advantageous
- Formal training in problem solving methods, test management, process validation or software validation would be advantageous
- Attention to detail.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate test implementation and results effectively.
- Understanding of quality system regulations.
- Understanding of R&D stage gate process
Typical test laboratory environment, with work also performed in R&D office environment, and customer/supplier locations.
For further information on this Design Assurance Technician role in Galway please contact Anna Carty on 086-8168298/ firstname.lastname@example.org
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