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 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

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 Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”