About the Role
Our client is a Medical Device company developing innovative non-surgical interventions for chronic inflammatory Sino-Nasal diseases. They are seeking an experienced Design Assurance Engineer to play a key role in supporting the lifecycle of their commercially released medical device products.
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The ideal candidate will have strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents. They should also have experience with design control and risk management throughout the product lifecycle, post-market surveillance, complaint investigations, and CAPA systems.
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Responsibilities include:
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* Supporting commercial projects from a Design Assurance perspective
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* Leading and executing product/material design changes for commercially released products in accordance with regulatory and internal quality system requirements
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* Maintaining and updating risk management files for post-market products
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* Generating Design Verification plans, protocols & reports, and executing DV testing to support product/material design changes
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* Ensuring continued design control compliance
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* Supporting complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions
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We are looking for a highly motivated individual with excellent communication and problem-solving skills. If you are interested in this opportunity, please get in touch.
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Benefits
This role offers an excellent salary, pension, healthcare, yearly bonus, and share options.
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Requirements
To be considered for this role, you will need:
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1. 2-3 years experience in a similar field
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2. Bachelor's degree (Level 8 NFQ)
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3. Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents
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4. Experience with design control and risk management throughout the product lifecycle
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5. Experience with post-market surveillance, complaint investigations, and CAPA systems
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Day-to-Day Responsibilities
This role will involve:
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* Supporting sustaining commercial projects from a Design Assurance perspective
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* Providing DA technical direction/input to process changes for commercially released products
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* Maintaining and updating risk management files for post-market products
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* Generating Design Verification plans, protocols & reports, and executing DV testing
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* Ensuring continued design control compliance
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* Supporting complaint handling by participating in technical investigations and root cause analysis
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