Design Assurance Engineer Galway

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Due to continious growth and success, our client are now expanding their technical teams and amongst these opportunities have an opening for a Design Assurance Engineer.

This is an opportunity to work closely with an extremley talented team of engineers across various departments in one of the most advanced medical device companies on the market.The Design Assurance Engineer provides input to our contract development teams in the design of highly complex medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. They are responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance.

Job Responsibilities:*Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.

*Works closely with product development engineering and the client team to establish the system design specifications and product requirements.

*Performs and documents all engineering studies and reports to satisfy the master verification plan.

*Participates with the engineering team to establish and review the design FMEA.

*Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.

*Support various QA/RA activities including quality management, system reviews, audits, etc.

*Evaluation of new products, assuring the safety and efficacy of the devices.

*Design verification and shelf life protocols / reports review.

*Root cause investigations; drive problem solving efforts for quality issues. Qualifications

*Candidates must have 3-5 years of relevant experience.

*Level 8 degree or higher in Engineering, or a related discipline.

Key Requirements

*Must be able to travel occasionally to meet with customers / project teams. To find out more about Real please visit www.realstaffing.comReal 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 and Wales