Senior Design Assurance Engineer

1 week ago

Galway, Galway, Ireland Medtronic Vascular Galway Uc Full time

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life Medtronic At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose Within our Structural Heart Design Assurance Group in Medtronic, plc, 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.
Come for a job, stay for a career
A Day in The Life Of: 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 lead strategies for risk management, 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.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Key Skills & Experience Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
Requires a minimum Level 8 degree in Engineering or other relevant discipline with minimum 4 years' relevant experience.
Experience in a highly regulated industry, preferably medical devices.
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.
Flexibility to travel

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