Job Title: Design Assurance Engineer
We are seeking an experienced Design Assurance Engineer to play a key role in supporting the lifecycle of commercially released medical device products.
The successful candidate will be responsible for managing design changes, ensuring compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of devices.
This position requires a minimum of 3 years' experience in the medical device industry, including experience with bringing products through regulated design control processes. The candidate must have knowledge with design verification and validation activities through to regulatory submission and commercialisation.
Key Responsibilities:
* Implement and promote best in class design assurance through the product lifecycle for Neurent Medical devices
* Ensure R&D projects are executed in accordance with industry standards
* Implement product verification and validation activities to support marketing applications for the device(s)
* Manage design changes and ensure continued compliance with risk management and design control requirements
* Support complaint investigations to uphold the safety and effectiveness of devices
Requirements:
* End to end design control experience
* 2-3 years experience in the medical device industry
* User requirements understanding and how to translate this through design outputs and verification & validation
About the Company:
A Medical Device company is looking for a Design Assurance Engineer to work as part of a growing team, requiring flexibility and willingness to carry out tasks outside of routine responsibilities.