Job Title: Validation EngineerLocation: Galway City, IrelandDepartment: QualityReporting To: Group Validation LeadContract Type: 24-Month Fixed TermOverview An exciting opportunity has arisen for a talented and experienced Validation Engineer to join a world-leading medical device manufacturer in Galway City. Representing our client, a global leader in cardiovascular technology, we are looking for a dynamic professional who can take ownership of Test Method Validation (TMV) activities and drive excellence in quality and compliance.Role Summary The successful Validation Engineer will play a critical role in developing, documenting, and implementing robust Test Method Validation (TMV) operating procedures. This position requires a strong understanding of ISO, PMDA, and FDA regulatory frameworks.Acting as the subject matter expert within cross-functional teams, the engineer will guide early-stage projects, execute validations across all inspection stages (incoming, in-process, and final product), and perform in-depth statistical analysis to ensure test methods are accurate, precise, and repeatable.Key ResponsibilitiesLead and manage Test Method Validation activities in line with regulatory and internal requirementsDevelop and approve Standard Operating Procedures (SOPs) and Master Validation Plans & ReportsEstimate validation timelines and resource requirements, and coordinate validation schedulesAuthor and review validation protocols, reports, and supporting documentationEnsure validation activities meet ISO 13485, PMDA, and FDA (21 CFR Part 820) standardsDrive risk management activities, including FMEA and related assessmentsPerform statistical analyses (e.g. Gage R&R, ANOVA) to evaluate test method performanceProvide training and mentorship to cross-functional teams on TMV best practicesCollaborate with external testing partners, reviewing methodologies, protocols and reportsEscalate risks or issues promptly and communicate progress to the Site Validation LeadCandidate Profile5–8 years of hands-on experience in medical device manufacturing or validation rolesMinimum Level 8 qualification in Science, Engineering, or related disciplineStrong technical knowledge of catheter-based medical devices will provide a distinct advantageIn-depth understanding of regulatory and validation requirements in the medical device sectorProven track record of delivering validation projects on time and to high quality standardsExcellent skills in data analysis, statistical techniques, and problem solvingComfortable working in a fast-paced, regulated environment with cross-functional teamsStrong interpersonal and communication skills across all business levelsFor further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ieCheck out all our open jobs on our HERO Recruitment website –https://www.hero.ie/
#J-18808-Ljbffr