Working with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Electrical standards testing, Software validation, Product and Process Validation, and Risk Management Activities.
- Support the design of medical electronic equipment (MEE) controllers with particular emphasis on electronics and software standards and testing.
- Performs technical reviews of design documentation, attends at design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
- Support new test development and appropriate validation
- Quality approver on all relevant records, tests, validations, reports, project file entries etc.
- Plan and conduct software validation on device and supporting software-based systems.
- QA lead for Product design transfer/validation strategy development and implementation.
- Supports external audits including notified body and FDA audits.
- Promotes the awareness of regulatory and customer requirements throughout the organization.
- A degree in Engineering, Technology, or Science
- At least 2-4 years’ experience working in a regulated device company, with experience in electronics testing and/or software validation preferable.
- Excellent planning and coordination skills plus verbal and written communication skills.
- Knowledge of mechanical ventilation and accessories would be advantageous
- Formal training in medical device risk management, problem solving methods, reliability engineering, process validation, software validation or human factors would be advantageous
- Excellent data analysis skills.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate quality / regulatory concepts effectively.
- Excellent understanding of ISO 13485 and FDA QS regulations.
- Understanding of R&D stage gate process
- Ability to understand and apply relevant medical device standards e.g. Electrical Safety, Usability, Respiratory Equipment, etc.
For further information on this Design Assurance Engineer role in Galway please contact Alan Prendergast on 0860462367/ firstname.lastname@example.org
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