A Major Medical Devices Company in Galway, Ireland is seeking to recruit a suitably qualified person for the following post:
DESIGN ASSURANCE ENGINEER
Within our Structural Heart Design Assurance Group, we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the Structural Heart devices we develop, is assured and maintained throughout the product lifecycle.
* You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.
* You will prepare test method validations, design verification and shelf life protocols / reports.
* You will be responsible for keeping abreast of industry best practice with respect to product design.
* You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialisation activities.
* You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.
* You will be required to provide Quality input into new product development, process improvements and change control.
* As required, you will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to standard requirements.
KEY SKILLS & EXPERIENCE
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, Science) and desirably with a minimum of 2 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.
Excellent communication and ability to influence is critical to the role. You must be fluent in English, both in writing and speaking.
The role is a day shift role. Flexibility to travel <10% of time desirable.
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland