Our client, a medical device company in Galway is currently looking to recruit a Senior Design Assurance Engineer for their site.
Within the Coronary Design Assurance Group, we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the coronary devices we develop, is assured and maintained throughout the product lifecycle.
- Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.
- Work on a cross functional team to support product EUMDR certification.
- Remediate products risk management files to ensure all EUMDR requirements are satisfied prior to the submission.
- Review and approve the Technical documentation files for the submissions.
- Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
- Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
- Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
- As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
The Ideal Candidate
- We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 5 years’ relevant experience.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Senior Design Assurance Engineer role in Galway please contact Alan on 0860462367 / firstname.lastname@example.org
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