**Design Assurance Engineer Role**
We are seeking an experienced Design Assurance Engineer to play a key role in supporting the lifecycle of our commercially released medical device products.
* The ideal candidate will have strong working knowledge of FDA QSR, ISO 13485, and ISO 14971, as well as experience with design control and risk management throughout the product lifecycle.
* A bachelor's degree (Level 8 NFQ) is required, and 2-3 years of experience in a similar role would be beneficial.
Key Responsibilities:
1. Support sustaining commercial projects from a Design Assurance perspective.
2. Lead and execute product/material design changes for commercially released products in accordance with regulatory and internal quality system requirements.
3. Provide DA technical direction/input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering.
4. Maintain and update the risk management file for post-market products.
5. Generation of Design Verification plans, protocols & reports and execution of DV testing to support product/material design changes and collection of shelf-life data to support regulatory submissions.
6. Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file maintenance, verification/validation planning, and traceability.
7. Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).
**Benefits:**
* Bonus
* Pension
* Healthcare