Design Assurance Engineer

**Design Assurance Engineer - Ballinasloe**

**The Company**:
My client are a medium sized Medical Device company focusing on the development of highly differentiated medical devices that are designed to address unmet clinical need. The Company mission is to improve the detection and treatment of disease, leveragingthe combination of expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities.

This role is based in their Ballinasloe site and offers a condensed four day working week.

**The Role**:
The Design Assurance Engineer in this role will be responsible for providing quality engineering support for all phases of product development process and supporting sustaining engineering activities after product commercialisation.

**The Package**:
Competitive salary, annual bonus scheme, pension, family healthcare, stock options, hybrid working, four day condensed working week.

**Responsibilities**
- Participate in new product/technology development and support DA activities as part of an overall project team.
- Provide guidance in the areas of design control and risk management.
- Develop and execute test method validations.
- Develop design verification, design validation, and usability plans, protocols, and reports.
- Supports post market activities including but not limited to
- generating field assessment and post market surveillance reports.
- Support design transfer activities including process validation and material qualifications.
- Provide Design Assurance representation for nonconformance reports, complaints, internal and external audit findings and CAPAs

**Requirements**:

- Degree in Science, Engineering or a related discipline
- Minimum of 3 years of experience in a Quality Assurance role in a manufacturing setting in the Medical Device industry
- Strong understanding off Design Assurance, Product Development, Risk Management and Change Controls in relation to the development and manufacture of Medical Devices

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales