Role: Design Assurance Engineer
Location: Oranmore, Galway (Hybrid working)
Benefits: Excellent salary, pension, healthcare, yearly bonus and share options.


Company:
My client is a Medical Device company developing highly innovative non-surgical interventions that treat chronic inflammatory Sino-Nasal diseases. They are looking for a Design Assurance Engineer to work play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of our devices


Requirements:

• 2-3 years experience (can be from MNC or start up)
• Bachelor’s degree (Level 8 NFQ)

• Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents.
• Experience with design control and risk management throughout the product lifecycle,
• Experience with post-market surveillance, complaint investigations, and CAPA systems.

• Support sustaining commercial projects from a Design Assurance perspective
• Lead and execute product / material design changes for commercially released products in accordance with regulatory and internal quality system requirements

• Provide DA technical direction / input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering.

• Maintain and update the risk management file for post-market products
• Generation of Design Verification (DV) plans, protocols & reports and execution of DV testing to support product / material design changes and collection of shelf-life data to support regulatory submissions.
• Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file (DHF) maintenance, verification/validation planning, and traceability.
• Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).