Project Engineer

Morgan McKinley; Dún Laoghaire-Rathdown; On-site; EUR 85,000 - 110,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Cross-functional leadership

Project management

Regulatory knowledge

Product lifecycle management

ISO GMP FDA knowledge

Engineering change control

Risk management

Stakeholder communication

Education

Bachelor's degree in Engineering

Job description

Senior Project Manager – Medical Devices

Location: Dublin

Industry: Medical Devices / Regulated Manufacturing

The Opportunity

We are seeking an experienced Senior Project Manager to join a leading medical device manufacturing organisation in Dublin. This is an exciting opportunity to lead cross-functional projects supporting a portfolio of innovative injection products, with a focus on product lifecycle management, regulatory compliance, business continuity and manufacturing improvements.

Working closely with Engineering, Quality, Regulatory, Operations and other key stakeholders, you will play a central role in delivering projects that support product changes, cost reduction, line extensions and ongoing business growth.

The successful candidate will bring strong project management experience within a regulated medical device or pharmaceutical environment, alongside the ability to coordinate technical teams and deliver complex projects to agreed timelines and quality standards.

Key Responsibilities

• 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.

The Ideal Candidate

• 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.

What's on Offer

• Opportunity to lead projects supporting a critical medical device product portfolio.
• Exposure to cross-functional engineering, manufacturing and regulatory initiatives.
• A collaborative environment with strong technical and business stakeholder engagement.
• Competitive salary and benefits package.
• Long-term career development within the medical device industry.