A Major Medical Devices Company in Galway, Ireland is seeking to recruit a suitably qualified person for the following post:
DESIGN ASSURANCE ENGINEER
Within the Coronary 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 coronary devices we develop, is assured and maintained throughout the product lifecycle.
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.
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