Job Title: Validation Engineer
Location: Galway City, Ireland
Department: Quality
Reporting To: Group Validation Lead
Contract Type: 24-Month Fixed Term
Overview 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 Responsibilities
* Lead and manage Test Method Validation activities in line with regulatory and internal requirements
* Develop and approve Standard Operating Procedures (SOPs) and Master Validation Plans & Reports
* Estimate validation timelines and resource requirements, and coordinate validation schedules
* Author and review validation protocols, reports, and supporting documentation
* Ensure validation activities meet ISO 13485, PMDA, and FDA (21 CFR Part 820) standards
* Drive risk management activities, including FMEA and related assessments
* Perform statistical analyses (e.g. Gage R&R, ANOVA) to evaluate test method performance
* Provide training and mentorship to cross-functional teams on TMV best practices
* Collaborate with external testing partners, reviewing methodologies, protocols and reports
* Escalate risks or issues promptly and communicate progress to the Site Validation Lead
Candidate Profile
* 5–8 years of hands-on experience in medical device manufacturing or validation roles
* Minimum Level 8 qualification in Science, Engineering, or related discipline
* Strong technical knowledge of catheter-based medical devices will provide a distinct advantage
* In-depth understanding of regulatory and validation requirements in the medical device sector
* Proven track record of delivering validation projects on time and to high quality standards
* Excellent skills in data analysis, statistical techniques, and problem solving
* Comfortable working in a fast-paced, regulated environment with cross-functional teams
* Strong interpersonal and communication skills across all business levels
For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie
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