Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site on a fixed term contract
Within our Design Assurance Group, we focus on ensuring our life support products are viable, reliable and compliant with relevant standards. Design Quality Engineering are directly involved in making sure our products design and documentation files are maintained through the full product lifecycle and that improvements and changes are implemented to comply with evolving global standards.
- You as a Design Quality Engineer will provide quality engineering support to Value Engineering projects, specifically for ventilators and accessories.
- The Design Quality Engineer will facilitate the application of design controls for all sustaining changes, as well as reviewing product design changes for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
- You will ensure that changes to existing products are conducted in compliance with the internal and external requirements (e.g. FDA, ISO) with evidence demonstrating effective implementation of design controls.
- You will be part of a cross-functional team who will review Product Requirements, for continuous improvement opportunities, while ensuring conformance to applicable requirements.
- You will provide support in the creation of verification and validation test plans.
- You will oversee testing and analysis for standards and product requirements compliance and provide guidance and direction for sample size and statistical analysis of verification and validation test results while utilizing Statistics tools, e.g. Minitab.
- You will exhibit a familiarity with regulatory requirements (e.g. ISO 13485, CFR 820 & EN ISO 14971), with a working knowledge utilizing ISO14971. You will demonstrate familiarity with relevant industry standards applicable to electro-mechanical medical equipment, e.g. IEC60601 series, particularly 60601-1-2, 60601-1-8, and 60601-2-12.
- We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 7 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 5 years relevant experience.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams. You are experienced to a competent level within Medical Device product design. Initiates and leads change, collaborates and creates alignment, drives accountability and thinks critically and makes sound decisions are a must.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Design Assurance Engineer role in Galway please contact Bimi Felix on 0868395533 / firstname.lastname@example.org
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