Contract: 18 months with possible extension
Location: Galway, Ireland
Kelly FSP is recruiting on behalf of one of our top medical devices clients. We are seeking a Junior Research and Development Engineer located in Galway, Ireland.
You will collaborate with the Sustaining and Lifecycle Management (LCM) team to support R&D activities for our portfolio of products designed to treat hemorrhagic and ischemic stroke. This role involves overseeing various aspects of the product lifecycle, including device performance testing for material changes, process improvements, regulatory submissions, shelf life studies, addressing sales and marketing requests, and investigating returned products.
The responsibilities and the impact YOU will have:
* Plan and execute Design Verification testing in a GxP environment.
* Perform data analysis and prepare test reports.
* Collaborate in defining evaluation and testing strategies for product/process changes.
* Support regulatory submissions.
* Create and/or update component specifications.
* Investigate product complaints and analyze returned devices.
* Support CAPA and Non-conformance processes.
* Contribute to the project team to achieve key objectives, meeting performance, time, and cost targets.
* Leverage and liaise with external vendors/resources to achieve project goals.
* Write procedures, protocols, specifications, and reports.
* Understand physician (user) techniques and clinical needs (disease state), and assist in developing product training materials.
* Perform other duties as assigned or required.
We would love to hear from YOU, if you have the following essential requirements:
* Honours degree in Mechanical or Biomedical Engineering or equivalent.
* Approximately 12 months of experience in a medical device design or manufacturing environment.
* Knowledge or hands-on experience with stent design.
* Design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
* Data review and statistical methods skills (Minitab).
* High level of technical writing and reporting skills.
* Strong work ethic, creative problem-solving, and capable of working on own initiative.
Desirable:
* Results and deadline-driven with the ability to handle multiple tasks and operate in a fast-paced environment.
* Design experience with SolidWorks, prototyping, and testing.
* Excellent interpersonal skills and the ability to work with people to achieve results.
* Highly motivated and an enthusiastic self-starter with the ability to work independently and as part of a team.
* Specific experience with medical devices, cardiovascular or neurovascular implants, or instruments.
This is what awaits YOU:
This is an opportunity to work with a ground-breaking biomedical company. We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities.
We offer:
* An opportunity to be part of a global market leader.
* A dynamic and inspiring working environment.
* Opportunities to work on challenging projects and assignments.
* Possibilities for further personal and professional development/education.
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