Social network you want to login/join with:
col-narrow-left
Client:
TEAM HORIZON
Location:
Dublin, Ireland
Job Category:
Other
-
EU work permit required:
Yes
col-narrow-right
Job Reference:
109e2b19dec6
Job Views:
8
Posted:
24.06.2025
Expiry Date:
08.08.2025
col-wide
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.
#J-18808-Ljbffr