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Client:
TEAM HORIZON
Location:
Dublin, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
109e2b19dec6
Job Views:
118
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
Team Horizon is seeking an Engineer, Device Risk Management for our global client in Dublin. This role will support new and ongoing risk management (RM) programs.
Why you should apply:
1. Join a company that is committed to helping create healthier communities worldwide through education, outreach, and better access to treatment.
2. Be part of a diverse, inclusive, and authentic workplace that offers competitive salaries, benefits & career progression opportunities.
What you will be doing:
1. Understanding the application of design control and ISO risk management and ability to execute program deliverables within this framework.
2. Conduct research and collaborate with the team to deliver Risk Management Plans, RM Reports, and Risk Benefit Analysis.
3. Support the delivery of design input documentation to meet the timelines of the stage-gate design review process and contribute to the resulting regulatory submissions, reporting the culmination of the device risk management program through the final risk benefit analysis.
4. Contribute to early-stage development and risk assessments and assess Risk Management files through the routine review program as required, including monitoring the competitor landscape and review of medical device reports and product recalls.
5. Collaborate with Device Development colleagues, Clinicians, and Pharmacovigilance teams to analyze, evaluate, mitigate, and control risks at the user interface in line with international standards and our Quality Management System.
6. Support all stages of device development as part of design reviews through the completion of Risk Management documentation in a timely manner.
7. Actively promote Risk Management ethos across GDD through contribution to collaborative work practices.
8. Contribute to cross-functional teams to support regulatory submissions for new products.
9. Support other Risk Management colleagues to ensure functional deliverables are met in line with GDD priorities.
10. Any other duties as assigned.
What you need to apply:
1. Third Level Qualification Engineer or Designer with demonstrable understanding and application of Design Controls per 21 CFR .30 and Risk Management per ISO :.
2. 2-4+ years relevant experience is desirable but not essential.
3. Demonstrable understanding and application of the fundamental principles of Medical Device Risk Management within the regulatory framework of FDA 21 CFR .30.
4. Demonstrable understanding and application of Design, Use, and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs, and Medical Hazard Analysis.
5. Design Controls (21CFR .30) / Risk Management (ISO :).
6. Familiarity with new product introduction/development (NPI/NPD).
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