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Niamh Hlubek
Life Science

+353 87 114 6347
[email protected]
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Details

R&D Engineer II


Reference:NHL/AYSC-830810 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Research and Development Engineer

NHL/AYSC-830810

R&D Engineer II- Galway

The R&D Engineer II works as parts of the R&D team tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations.

Responsibilities

Develop Products and corresponding processes which meet the customer requirements throughout the design phase.
May act as a technical lead on a project.
Generate technical documentation for the Product Design History File and Device Master Records.
Develop test methods for product evaluation and validation. Develop and execute test method validations.
Liaise where necessary with Business Development and Physicians to understand and validate the specific market requirements in any given product segment.
Partner with Manufacturing Engineering, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
Support Manufacturing post product commercialization.
As part of the R&D team, contribute effectively to the broader technical and resource needs of the team while ensuring specific technical expertise is continually developed and strengthened.


Qualifications

An Engineering or Science Degree.
Experience within a Medical Device environment with 3-5 years spent in the R&D Dept.

Competencies and Attributes

Demonstrable detailed working knowledge of the medical device industry.
A good knowledge of design life cycles requirements.
Track record of successful impact on projects.
An analytical approach to problem solving.
Is creative, continually learning and exploring new ideas. May be a technical authority on certain aspects of a project.
A self-starter who proactively enacts change, applies his/her own initiative in most situations and drives continuous improvement.
A good team player who works well in a small team environment.
A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
Capacity to make sound judgements while learning from mistakes.
Good understanding and application of project management tools.
Effective knowledge of the regulatory environment in which the business operates.
Attention to detail while maintaining awareness of longer-term objectives.
Strong interpersonal skills, a demonstrated ability to influence his/her peers.
Displays the highest levels of integrity.
Capacity to maintain the highest levels of confidentiality internally and externally.



Any applicant must have an existing valid work permit/ visa to apply. (Stamp 4 or EU passport).
Reach out to [email protected] or 087-1146347 for more details.