Senior Medical Device Project Manager

Morgan McKinley; Dún Laoghaire-Rathdown; Presencial; EUR 85.000 - 110.000; Jornada completa

Descripción de la vacante

Morgan McKinley is seeking an experienced Senior Project Manager to join a leading medical device manufacturing organisation in Dublin. You will lead cross-functional projects across Engineering, Quality, Regulatory and Operations to deliver lifecycle changes, compliance improvements and cost-efficient manufacturing enhancements.

The role focuses on coordinating technical teams, managing timelines and budgets, and ensuring adherence to ISO, GMP and FDA requirements.

Formación

• Bachelor's degree in Engineering, Technology or a related discipline.
• Minimum 5 years' experience within a regulated medical device and/or pharmaceutical environment.
• Proven experience managing cross-functional technical or engineering projects.
• Experience with product lifecycle management within a manufacturing environment.
• Strong understanding of structured product development processes and engineering change control.
• Knowledge of ISO standards, GMP, FDA regulations, medical device design controls and manufacturing scale-up processes.
• Experience coordinating multidisciplinary teams and managing multiple project stakeholders.
• Strong project planning, risk management, communication and organisational skills.
• Ability to manage competing priorities while maintaining a strong focus on quality, compliance and project delivery.

Responsabilidades

• Lead cross-functional projects supporting product changes, regulatory compliance, cost reduction, line extensions and business continuity.
• Manage projects from initiation through to implementation, ensuring delivery against agreed scope, timelines, budgets and quality requirements.
• Act as the primary point of contact between business leadership, functional managers and project team members.
• Coordinate technical subject matter experts to define project deliverables, activities, resources and milestones.
• Develop and maintain detailed project plans, schedules and risk assessments.
• Facilitate regular project meetings, ensuring stakeholder alignment and timely completion of actions.
• Assess change requests and evaluate their impact on project scope, cost, schedule and risk.
• Manage engineering change deliverables through formal Change Control processes.
• Work closely with Engineering, Quality, Regulatory, Operations and other functions to ensure compliance with relevant quality systems and regulatory requirements.
• Provide regular project status updates to senior management, covering progress, risks, quality, schedule and cost.
• Promote strong project planning, execution discipline and continuous improvement across project activities.

Conocimientos

Cross-functional leadership

Project management

Regulatory knowledge

Product lifecycle management

ISO GMP FDA knowledge

Engineering change control

Risk management

Stakeholder communication

Educación

Bachelor's degree in Engineering

Descripción del empleo

Morgan McKinley is seeking an experienced Senior Project Manager to join a leading medical device manufacturing organisation in Dublin. You will lead cross-functional projects across Engineering, Quality, Regulatory and Operations to deliver lifecycle changes, compliance improvements and cost-efficient manufacturing enhancements.

The role focuses on coordinating technical teams, managing timelines and budgets, and ensuring adherence to ISO, GMP and FDA requirements.