Design Assurance Engineer

CAREERWISE RECRUITMENT

GALWAY

A Design Assurance Engineer is required by CareerWise Recruitment for our Galway based client. The Design Assurance Engineer provides input to the 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. Please contact Tom Devaney for more information. THE ROLE: * 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. REQUIREMENTS: * Candidates must have 3-5 years of relevant experience with a Bachelors degree or higher in Engineering, or a related discipline. * Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations. * Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers. * Must be able to travel occasionally to meet with customers / project teams. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1472 days ago