|Role Type||Fixed Term Contract|
Senior Design Engineer (Post Market)
Job ID: JOB-11931
Senior Post Market Design Assurance Engineer- Initial 12 Month FTC
A globally leading medical device manufacturer are currently seeking to attract a Senior Design Assurance Engineer to join their their post market team. This role is based in Galway and is commutable from Mayo, Limerick & Clare.
- You will be responsible for leading Post Market initiatives within the Coronary/RDN Design Assurance function.
- You will provide governance and leadership to establish best practice in accordance with ISO13485/14971, 21 CFR and Corporate Quality standards and Regulatory requirements.
- You will establish strong working cross functional relationships across the organization and with partners within a complex technical environment.
- You will be able to demonstrate effective negotiation skills, while being able to see and address business implications of decisions.
- You will engage with risk management teams consisting of matrixed resources by providing focused technical guidance.
- You will lead field issue investigations when requested, author IIA documents as assigned and provide expert input into Field Corrective Action Plans.
- You will represent the CRDN Post Market department in supporting internal and external audits (MDR/MDSAP/FDA etc…)
- You will contribute to the continuous improvement strategies and change management initiatives within the function, maintaining performance reports and KPI’s.
- You must be capable of leading and driving projects / sub-projects as necessary.
- Critically access data sets – identifying trends/signals – drive a preventive action ethos
- 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 5 years relevant experience.
- 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.
- You are a good communicator and fluent in English, both in writing and speaking.
- Experience in some form of technical writing beneficial
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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