Engineer, Device Risk Management

Found in: Talent IE C2 - 3 weeks ago


Dublin, Ireland TEAM HORIZON Full time
Description

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 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 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 .30 and Risk Management per ISO :.
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 .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 .30) / Risk Management (ISO :).
Familiarity with new product introduction/ development (NPI)/ NPD).

  • Manager, Device Program Lead

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland TEAM HORIZON Full time

    Description Team Horizon is seeking a Manager, Device Program Lead for our global client based in Dublin. In this role you will ensure Project Management using advanced program management skills to lead cross-functional teams in the development and delivery of robust and high-quality injectable drug-device technologies. The role may span multiple...

  • Senior Device Design Engineer

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland Viatris Full time

    McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...

  • Senior Manager, Device Program Lead

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland TEAM HORIZON Full time

    Description Team Horizon is seeking a Senior Manager, Device Program Lead for our global client based in Dublin. 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...

  • Territory Manager- Medical Devices

    Found in: beBee jobs IE - 3 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    I am currently looking for a Territory Sales Manager who has experience selling medical devices into hospitals.This person will cover the greater Leinster Area, based out of Dublin.Looking for someone who has experience selling bespoke medical devices and who is passionate to excel in a sales roleIf this sounds like an opportunity that could be suitable for...

  • Risk Manager

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland Turner & Townsend Full time

    Company Description At Turner & Townsend we’re passionate about making the difference. That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 130...

  • Risk Manager

    3 weeks ago


    Dublin, Ireland Turner & Townsend Group Full time

    At Turner & Townsend we’re passionate about making the difference. That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create a prosperous society. Every day we help our major global clients deliver ambitious and highly technical projects, in over 130 countries worldwide. Our team...

  • Risk Manager, IT

    3 weeks ago


    Dublin, Ireland Hudson River Trading Full time

    Hudson River Trading is hiring a Risk Manager with a strong background in technology risk management to join our Risk team. This role is based in our Dublin office. As a Risk Manager, you will be responsible for providing guidance on enterprise frameworks and methodologies that relate to technology controls. You’ll develop ongoing technology risk...

  • Support Engineer.

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland Millennium Management Full time

    Support Engineer The End User Service Support Technician is responsible for providing quality support services to the various groups in a fast pace financial company. This requires the ability to handle various problems with expertise and exceptional judgment while working with end-users. You will be part of a wider global team, so should be self-motivated,...

  • Risk Manager

    Found in: Talent IE C2 - 3 weeks ago


    Dublin, Ireland Primark Full time

    Job Description Risk Manager Our risk teams are right at the heart of what we do. Surrounded by some of the best risk specialists in the industry, you’ll bring your own ideas to the business - helping to shape the experience of our customers as part of a forward-thinking team.  As a key...


  • Dublin, Ireland Cpl Healthcare Full time

    I am currently looking for a Territory Sales Manager who has experience selling medical devices into hospitals. This person will cover the greater Leinster Area, based out of Dublin. Looking for someone who has experience selling bespoke medical devices and who is passionate to excel in a sales role! If this sounds like an opportunity that could be...

  • Risk Manager

    Found in: beBee S IE - 4 weeks ago


    Dublin, Ireland Primark Ireland Full time

    Risk ManagerOur risk teams are right at the heart of what we do. Surrounded by some of the best risk specialists in the industry, you’ll bring your own ideas to the business - helping to shape the experience of our customers as part of a forward-thinking team. As a key member of the Primark Risk and Compliance team, you will provide leadership, structure...

  • Territory Manager- Medical Devices

    Found in: beBee S IE - 3 weeks ago


    Dublin, Ireland Cpl Full time

    I am currently looking for a Territory Sales Manager who has experience selling medical devices into hospitals.This person will cover the greater Leinster Area, based out of Dublin.Looking for someone who has experience selling bespoke medical devices and who is passionate to excel in a sales role!If this sounds like an opportunity that could be suitable for...


  • Dublin, Dublin City, Ireland Trinity College Dublin, The University of Dublin Full time

    Applications are invited for the following postdoctoral researcher position for the following project: Bench-Top Testing of Implantable Urological DevicesThe position will be based in the Lally Lab ) in the Trinity Centre for Biomedical Engineering (TCBE) within the Advanced Materials and Bioengineering Research Centre (AMBER) centre. The goal of the Lally...

  • Software Design Assurance Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    On behalf of our client, a growing medical technology company based in Dublin, we are currently recruiting for a Software Design Assurance Engineer. The Software Design Assurance Engineer will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and...

  • Support Engineer

    7 days ago


    Dublin, Ireland Millennium Management LLC Full time

    95 open jobs.  Use your resume to get matched with the right job. 95 open jobs.  Use your resume to get matched with the right job. Upload your resume Dublin, Ireland Information Technology Dublin, Ireland Information Technology Data Scientist / Analyst - Systematic Data Platform Hong Kong, Hong Kong Information Technology Full Stack Engineer -...

  • Senior Risk Manager

    3 weeks ago


    Dublin, Ireland Mace Group Full time

    The opportunity – Senior Risk Manager (project not enterprise) - Dublin, Ireland Project: Mace are looking for a Risk Manager to join our project controls team and work on large scale and complex Infrastructure projects in Dublin. Your responsibilities will include: Accountable for the risk management performance on their assigned commission(s). ...


  • South Dublin, Ireland First Ireland Risk Management Ltd Full time

    First Ireland Risk Management is seeking to recruit ambitious and self-motivated Sales Executives to join our Personal Lines Sales Division.We are one of the largest brokerages in Ireland employing over 130 people, with our main office is Parkgate Street, Dublin.This vacancy is based in our Head Office in Parkgate Street, Dublin 8. Responsibilities: ...

  • Senior NPI Engineer

    Found in: beBee jobs IE - 2 weeks ago


    Dublin, Dublin City, Ireland CPL Healthcare Full time

    Senior NPI Engineer My client, a global partner for the design, development and manufacture of medical devices, are looking tohire a NPI Engineer on a permanent basis. This role will suit someone coming from a regulated manufacturing environment and capable of overseeing the planning and co-ordinating New Product Design This is a permanent onsite role,...

  • Packaging Development Engineer

    Found in: Talent IE C2 - 3 weeks ago


    Dublin 2, Ireland Adaptive HVM Ltd Full time

    Job DescriptionThe successful candidate will be responsible for providing technical and/or engineering support for Finished Product (FP) manufacturing, providing packaging engineering support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine FP commercial manufacturing. This involves...


  • South Dublin, Ireland First Ireland Risk Management Ltd Full time

    First Ireland Risk Management are inviting Applications for a position as Business Insurance Account Executive within the Business Insurance Division at our Head Office in Parkgate Street, Dublin 8 due to our continued expansion. The Ideal Candidate will have: Be an Account Executive within the Administration Team and be able to demonstrate strong...