Project Engineer

Morgan McKinley; Dún Laoghaire; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career development opportunities

Job summary

Morgan McKinley in Dublin is seeking a Senior Project Manager to lead cross-functional projects for a portfolio of innovative medical devices. You will drive lifecycle management, regulatory compliance, and manufacturing improvements, coordinating Engineering, Quality, Regulatory, and Operations to deliver projects on time and within budget.

The ideal candidate will have 5+ years of experience in a regulated medical device or pharmaceutical setting, strong leadership, and a proven track record

Qualifications

• Bachelor's degree in Engineering, Technology or 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.

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 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 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 scope, cost, schedule and risk.
• Manage engineering change deliverables through formal Change Control processes.
• Work closely with Engineering, Quality, Regulatory, Operations to ensure compliance with 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

Project management

Cross-functional leadership

Regulatory compliance

Quality systems

Risk management

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.