Joining a highly motivated team of Post Market Engineers within the Coronary/RDN Design Assurance function
Provide Design Assurance support to various OU Sustaining & product Surveillance initiatives
Drive Engagement & mindfulness initiatives ensuring the wellbeing of yourself and your colleagues
Contribute to establishing best practice in accordance with ISO13485/14971, 21 CFR and Corporate Quality standards and Regulatory requirements
Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment
Engage with risk management teams consisting of matrixed resources by providing focused technical guidance
Represent the CRDN Post Market department in supporting internal and external audits (MDR/MDSAP/FDA etc)
Contribute to the continuous improvement strategies
Requirements
Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science)
Minimum 4 years relevant experience
Dynamic team player working effectively and proactively on cross-functional teams
Ability to initiate and lead change, collaborate, create alignment, drive accountability, think critically and make sound decisions
A good communicator and fluent in English, both in writing and speaking
Experience in some form of technical writing beneficial
A working knowledge of Regulatory Standards as applicable
Some formal knowledge of Complaint trending or Post Market Surveillance would be considered beneficial