Design Assurance Engineer

Permanent Engineers

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:

3-4 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 ...