Telephone: 086 8395533
Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site.
- You will contribute to the product development team and be responsible for supporting activities required to ensure reliability of the design.
- You will work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population.
- You will be required to communicate key program information including exceptions, barriers & Quality Issues to the Quality Core Team Member, extended team & functional management to ensure full engagement & alignment.
- You will be responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support product approval and release.
- You will be leading root cause investigations & drive problem solving efforts for quality issues.
- You will support risk management activities, application of DRM principles, regulatory submissions and support customer complaint analysis and post market surveillance activities.
- As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities. You will generate and approve change requests
- We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 2 years relevant experience.
- Experience in design of Medical Electrical equipment ( IEC60601) would be beneficial .
- You are a dynamic team player can work effectively and proactively on cross-functional teams. 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 086 8395533 / firstname.lastname@example.org
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