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R&D Process Validation Engineer II - 23 month contract - Job Opportunity at Medtronic

Athlone, Ireland
Contract
Mid-level
Posted: August 1, 2025
On-site
€55,000 - €70,000 annually based on Ireland's competitive medical device sector, Medtronic's market position as a premium employer, and the specialized nature of EU MDR compliance expertise in the current regulatory environment

Benefits

Competitive salary package positioned to attract mid-level engineering talent in the Irish medical device market
Flexible benefits package allowing customization based on individual needs and life circumstances
Comprehensive healthcare coverage typical of multinational medical device companies
Professional development opportunities within a global R&D environment
Access to cutting-edge medical device technologies and innovation projects
International career progression opportunities within Medtronic's global network

Key Responsibilities

Lead EU MDR compliance initiatives by developing and executing process validation protocols that ensure regulatory adherence across European markets, directly impacting product market access and revenue protection
Drive strategic validation planning by identifying gaps in Project Validation Master Plans and establishing critical timelines that support business continuity and regulatory milestones
Partner with cross-functional manufacturing and quality teams to establish and maintain quality standards that protect brand reputation and ensure patient safety across global markets
Execute comprehensive risk management strategies including FMEA and Fault Tree Analysis to proactively identify and mitigate potential product failures that could result in costly recalls or regulatory actions
Design and implement advanced inspection and testing mechanisms while conducting statistical analyses that optimize manufacturing costs and ensure product specifications meet stringent medical device standards
Ensure corrective measures meet reliability standards while maintaining documentation compliance that supports regulatory submissions and audit readiness
Drive continuous improvement initiatives by recommending procedural changes and updating standard operating procedures that enhance operational efficiency and regulatory compliance
Build strategic partnerships with cross-functional teams to develop inspection methodologies that ensure effective product acceptance and quality assurance processes

Requirements

Education

Level 8 Degree in a relevant Quality/Engineering/Science related discipline

Experience

2 – 3 years relevant experience in a medical devices or similar regulated environment

Required Skills

Medical Device Process Validation experience Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly Knowledge of Quality Systems, validation standards, policies, procedures and methodologies Knowledge, understanding and implementation of GAMP5 Practical working knowledge of statistical data analysis and quality improvement tools and techniques Dynamic team player and leader with ability to work effectively on cross-functional teams Self-directed with ability to interface with various organizational levels Patient and customer focused with high standards and operational excellence Excellent written, documentation, and oral communication skills with fluency in English Excellent organizational skills with ability to prioritize multiple projects Good communication skills
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented regulatory changes with the EU MDR implementation creating massive demand for validation engineers who can navigate complex compliance requirements. Companies are investing heavily in validation capabilities to maintain market access across European territories, driving significant job creation in this specialized field. Digital transformation in medical device manufacturing is accelerating the adoption of statistical analysis tools and data-driven validation approaches, making professionals with both traditional validation skills and modern analytical capabilities highly sought after in the current market. Post-Brexit regulatory landscape has created unique opportunities in Ireland as medical device companies establish or expand EU operations, positioning Irish validation engineers at the center of strategic regulatory compliance initiatives for major multinational corporations.

Role Significance

Typically works within a validation team of 5-8 professionals, collaborating across manufacturing, quality, and R&D departments with exposure to senior management through critical compliance projects and regulatory milestone reporting.
Mid-level position with significant strategic impact, involving direct responsibility for regulatory compliance initiatives that affect product market access and revenue generation. The role demonstrates clear progression from entry-level validation work while building toward senior technical leadership positions.

Key Projects

EU MDR compliance validation projects requiring comprehensive process documentation and regulatory submission support Cross-functional risk management initiatives using advanced analytical tools like FMEA and statistical process control Manufacturing process optimization projects that balance quality requirements with cost-effectiveness and operational efficiency Regulatory audit preparation and response activities that ensure continued market authorization and compliance standing

Success Factors

Deep understanding of EU medical device regulations combined with practical application experience in manufacturing environments, enabling navigation of complex compliance requirements while maintaining operational efficiency Strong analytical and statistical skills coupled with the ability to translate technical data into actionable business recommendations that support both regulatory compliance and commercial objectives Exceptional cross-functional collaboration abilities that enable effective partnership with diverse teams including manufacturing, quality, regulatory affairs, and senior management across different organizational levels Proactive problem-solving approach combined with attention to detail, essential for identifying potential compliance gaps before they become costly regulatory issues or product recalls

Market Demand

High demand driven by EU MDR compliance requirements, limited pool of experienced validation engineers, and Ireland's strategic importance as a European medical device manufacturing hub for multinational corporations

Important Skills

Critical Skills

EU MDR compliance expertise represents the most valuable skill in the current European medical device market, as companies face significant penalties and market access restrictions without proper validation documentation and regulatory adherence Statistical analysis and data interpretation capabilities are essential for modern validation roles, as regulatory bodies increasingly expect data-driven validation approaches and sophisticated analytical support for compliance submissions Cross-functional collaboration and communication skills are critical for success in validation roles that require coordination across manufacturing, quality, regulatory, and senior management teams with competing priorities and different technical backgrounds

Beneficial Skills

GAMP5 knowledge enhances career prospects in computerized system validation, an increasingly important area as medical device manufacturing becomes more digitized and automated Plastic processing expertise in extrusion, injection molding, and blow molding provides valuable manufacturing context that enables more effective validation protocol development and troubleshooting Risk management methodologies including FMEA and Fault Tree Analysis are becoming standard requirements for validation roles as companies adopt more proactive approaches to quality and compliance management

Unique Aspects

Contract position offering 23 months of intensive EU MDR compliance experience, providing accelerated exposure to regulatory changes that will define the next decade of European medical device market access
Direct involvement in EU MDR compliance projects positions the role at the center of one of the most significant regulatory changes in medical device history, offering unparalleled professional development in regulatory validation
Medtronic's global presence combined with Ireland's strategic EU location creates unique opportunities for international project involvement and career progression within the European medical device regulatory landscape
Combination of traditional manufacturing validation with cutting-edge statistical analysis and risk management tools provides comprehensive skill development that translates across the entire medical device industry

Career Growth

Typical progression to senior individual contributor roles within 2-3 years, with management opportunities available within 4-5 years for high performers who demonstrate leadership capabilities and strategic thinking

Potential Next Roles

Senior Process Validation Engineer with expanded project leadership responsibilities and mentoring duties for junior team members Validation Manager overseeing multiple validation projects and leading teams of validation professionals across different product lines Regulatory Affairs Specialist leveraging validation expertise to support broader compliance and regulatory submission activities Quality Assurance Manager combining validation experience with broader quality system oversight and strategic quality planning responsibilities

Company Overview

Medtronic

Medtronic stands as one of the world's largest medical technology companies with over 95,000 employees globally, specializing in medical devices, therapies, and healthcare solutions that serve millions of patients worldwide. The company maintains a strong focus on innovation and R&D investment, positioning it at the forefront of medical technology advancement.

Industry leader in medical devices with dominant market positions across multiple therapeutic areas including cardiovascular, diabetes, and surgical technologies. Medtronic's scale and resources provide employees with access to cutting-edge technologies and global career opportunities that smaller competitors cannot match.
Ireland operations serve as a critical European manufacturing and R&D hub, with Athlone facility playing a strategic role in serving European markets while benefiting from Ireland's favorable business environment and skilled workforce in the medical device sector.
Large corporation environment emphasizing innovation, patient focus, and operational excellence, with structured career development programs and global mobility opportunities balanced against the complexity and bureaucracy typical of Fortune 500 healthcare companies
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