Engineer, Device Risk Management

Team Horizon is seeking a 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 who are 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 offer competitive salaries, benefits & career progression opportunities.

 
What you will be doing:

• Understanding the application of design control and ISO14971 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 the resulting 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 and assess Risk Management files through the routine review program as required, including monitoring of the competitor landscape and review of medical device reports and product recalls.


• Collaborate with Device Development colleagues, Clinicians and Pharmacovigilance teams to analyse, evaluate, mitigate and control risks at the user interface in line with international standards and our Quality Management System.


• Supporting all stages of device development as part of design reviews through the completion of Risk Management documentation in a timely manner.


• Actively promote Risk Management ethos across GDD through contribution to collaborative work practices.


• Contributing to cross-functional teams to support regulatory submissions for new products.


• Supporting other Risk Management colleagues to ensure functional deliverables are met in line with GDD priorities.


• Any other duties as assigned.

 
What you need to apply:

• Third Level Qualification Engineer or Designer with demonstrable understanding and application of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019.


• 2-4+ years relevant experience is desirable but not essential.


• Demonstrable understanding and application of the fundamental principles of Medical Device Risk Management within the regulatory framework of FDA 21 CFR 820.30.


• Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis.


• Design Controls (21CFR 820.30) / Risk Management (ISO 14971:2019).


• Familiarity with new product introduction/ development (NPI)/ NPD).