Why Merit?At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.Summary Of DutiesAn opportunity now exists for a Design Assurance Engineer to join our Quality team in the Galway site. The successful candidate will provide routine and complex quality engineering work for specific product lines under broad supervision and guidelines.Duties & ResponsibilitiesProvide Design Assurance support in assigned Operations and R&D ProjectsProvide Technical expertise in establishing Design Inputs, Design Outputs and Test Method ValidationProvide technical expertise in Risk ManagementProvide support for QA system activities including audits, system reviews, and maintenance of the QMSProvide Support Design Verification and Design Validation ActivitiesExperience in problem solving and continuous improvement projects and activitiesQualification/ExperiencesLevel 7 Bachelor's Degree in Quality, Engineering or equivalent technical qualificationMinimum of 2 years' experience in a similar role / environmentGood working knowledge of quality systems and their application in a Design/manufacturing environmentGood working Knowledge of the Design Control ProcessExperience of statistics and a demonstrated knowledge of test method validationsDemonstrated working knowledge of 21 CFR 820, ISO13485, ISO14791, MDD & MDR regulatory standards and Medical Device industry practicesAbility to work under strict time constraints; meet deadlines in a timely manner with minimal guidanceTeam player: Ability to work and communicate effectively as part of QA and cross functional / organisational teams; be flexible with a 'can do' attitudeExcellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to clearly and informatively write technical documentation, routine reports, correspondence, procedures and work flows. Present numerical data effectively.Demonstrate organisational Merit Way values (HEART) in carrying out of all assigned responsibilities/tasks.PC Skills: Standard offices packages and ability to understand and learn customized computer software programsIJAKey BenefitsAttractive Salary packageDefined Contribution Pension PlanHealth Insurance CoverLife assuranceHealth & Wellbeing Events CalendarExcellent career progression opportunitiesRecognition schemeFree ParkingEducational assistanceInternal training coursesQuality Subsidised Canteens & Barista ServiceActive Sports and Social ClubWe are GlobalMerit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.Medtech Company of the Year WinnerMerit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.People DevelopmentAt Merit Medical Galway almost 60% of all roles are filled by internal employees We focus on encouraging, believing in and providing a platform for you to progress your careerCultureA supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite We value every employee as an individual.To see more on our culture, go to