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Client:
TEAM HORIZON
Location:
Dublin, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
109e2b19dec6
Job Views:
8
Posted:
24.06.2025
Expiry Date:
08.08.2025
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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:
Join a company committed to helping create healthier communities worldwide through education, outreach, and better access to treatment.
Be part of a diverse, inclusive, and authentic workplace that offers competitive salaries, benefits, and career progression opportunities.
What you will be doing:
Understanding the application of design control and ISO risk management and ability to execute program deliverables within this framework.
Conduct research and collaborate with team to deliver Risk Management Plans, RM Reports, and Risk Benefit Analysis.
Support the delivery of design input documentation to meet the timelines of the stage-gate design review process and contribute to regulatory submissions, reporting the culmination of the device risk management program through the final risk benefit analysis.
Contribute to early-stage development and risk assessments, assess Risk Management files through routine review, monitor the competitor landscape, and review medical device reports and recalls.
Collaborate with Device Development, Clinicians, and Pharmacovigilance teams to analyze, evaluate, mitigate, and control risks at the user interface in line with standards and QMS.
Support all stages of device development through timely completion of Risk Management documentation.
Promote Risk Management ethos across GDD through collaborative work practices.
Contribute to cross-functional teams for regulatory submissions of new products.
Support Risk Management colleagues to ensure deliverables meet GDD priorities.
Perform other duties as assigned.
What you need to apply:
Third Level Qualification in Engineering or Design with understanding and application of Design Controls (21 CFR .30) and Risk Management (ISO:).
2-4+ years relevant experience preferred but not essential.
Understanding of Medical Device Risk Management within FDA 21 CFR .30 framework.
Experience with analysis methodologies like FMEAs, FTAs, and Medical Hazard Analysis.
Knowledge of Design Controls and Risk Management standards.
Familiarity with NPI/NPD processes.
Note:
If you are not a passport holder of the country for the vacancy, you might need a work permit.
Check our Blog for more info.
Bank or payment details should not be provided when applying.
All applications should be made via the 'Apply now' button.
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