Design and Development Engineer I/II 
Contract Role
Onsite - Galway

Our Purpose

Coronary & Renal Denervation therapies are a vital component of our clients interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex Percutaneous Coronary Intervention (PCI). We are also leading the way with the transformational Blood pressure reduction therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.

Our team support the creation our market-leading portfolio of innovations. Combine the best of your experience with training and mentorship to move forward. If you want a challenging, energizing, rewarding career that changes lives, join us. Help us bring the next generation of life-changing medical technology to patients worldwide.

A Day in The Life Of:

• As a Design & Development Engineer II, you will actively participate in all areas of new product development including the following: Process design, Process characterisation, Technology development & advancement, Automation, Vendor, Sub Tier supplier management & Project management.
• Collaborate with cross functional teams to define, execute and deliver on requirements in the Pre and Post market space.
• Lead and support the process development, process characterisation, and process validation activities to support new product introduction. You should have excellent statistical capabilities and utilise design of experiments and engineering studies to coach team members on developing engineering DOE’s, transfer functions and build on our teams capabilities to root cause issues whilst defining robust process windows.
• Take initiative & lead, innovate and develop best in class process technology with emphasis on improving quality, reducing variation and developing state of the art automated and semi-automated systems.
• Identify and mitigate technology and process risks through the design process.
• Collaborate with team members on Design, Reliability & Manufacturability methodology (DRM), utilise 3-D drawing/printing and Augmented Reality to develop our best solutions that will allow us manufacture devices that will positively impact the healthcare of millions.
• Identify and carry out practical actions to solve technical problems using your skills in project management, six sigma tools, process characterisation and technology development.
• Collaborate, document, and present all learnings to project and functional teams.

Key Skills & Experience

• Third Level 8 Degree or higher in Electronic, Electrical, Mechanical, Biomedical Engineering, Science, or related discipline with a minimum 2 year relevant direct Science/Engineering experience within medical device environment. Advanced degree advantageous.
• Dynamic team player with the ability to collaborate effectively within a talented team and can work effectively and proactively on cross-functional teams.
• Experience in Process validation protocol and report writing.
• Ability to identify and resolve issues without direct supervision.
• Working knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability Studies.
• Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ)
• Knowledge of medical device processes with a good understanding of product and process design.
• Good communicator and fluent in English, with a high level of enthusiasm and motivation.
• Good organizational, presentation and project management skills are desirable