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Senior Validation Engineer - Job Opportunity at ICDS Recruitment Consultants

Dublin, Ireland
Full-time
Senior
Posted: May 3, 2025
On-site
EUR 75,000 - 95,000 annually based on Dublin market rates for senior validation roles in medical devices

Key Responsibilities

Lead technical validation and APQP lifecycle management, overseeing complex medical device manufacturing processes
Direct design transfer process implementation and validation strategy development aligned with regulatory requirements
Manage validation engineering team, ensuring compliance with GMP and industry standards
Drive continuous improvement initiatives and process optimization across manufacturing operations
Oversee risk management through PFMEA and control plan development
Coordinate with Quality, Operations, and Engineering teams for process validation execution

Requirements

Education

BSc / BEng or a similar relevant technical degree

Experience

5 years high-volume engineering experience in medical device manufacturing, 3 years validation experience

Required Skills

Statistical techniques Minitab Six Sigma (preferably Green Belt) Sampling Plans/Sizes Process development experience (DOE's) Risk Analysis/Risk Management FMEA's Strong documentation skills Strong interpersonal and communication skills Process validation Strong technical and problem-solving skills

Certifications

Six Sigma Green Belt (preferred)
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in medical device manufacturing is driving demand for validation expertise, particularly with EU MDR implementation Digital transformation in validation processes is creating need for data analytics and electronic validation system knowledge Growing focus on process automation and Industry 4.0 integration in medical device manufacturing requires advanced validation approaches

Role Significance

Typically leads team of 3-5 validation engineers with matrix management of cross-functional teams
Senior technical leadership position with significant influence on product quality and regulatory compliance

Key Projects

New product validation and transfer projects requiring 6-12 month implementation cycles Process optimization initiatives focusing on efficiency and quality improvements Regulatory compliance programs and audit preparation activities

Success Factors

Strong understanding of medical device regulatory landscape and validation requirements Ability to balance technical expertise with team leadership and stakeholder management Experience with risk-based validation approaches and statistical process control

Market Demand

High demand due to expanding medical device sector in Ireland and stringent regulatory requirements

Important Skills

Critical Skills

Advanced validation methodology expertise essential for ensuring regulatory compliance Statistical analysis and DOE capabilities crucial for process optimization Risk management and FMEA experience critical for product quality assurance

Beneficial Skills

Knowledge of electronic validation systems and digital quality management tools Experience with lean manufacturing principles Understanding of automation and Industry 4.0 concepts

Unique Aspects

Role combines technical leadership with validation strategy development
Position offers exposure to advanced medical device manufacturing processes
Opportunity to influence validation standards and quality systems

Career Growth

2-4 years in role before progression to higher management positions

Potential Next Roles

Validation Manager Quality Systems Manager Technical Operations Director

Company Overview

ICDS Recruitment Consultants

ICDS Recruitment Consultants specializes in technical and engineering placements for Ireland's growing medical device sector

Well-established recruitment firm serving major medical device manufacturers in Ireland
Strong presence in Dublin's medical device manufacturing hub
Professional services environment with focus on technical expertise and industry knowledge
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