Job title:Project Manager
Location:Dublin 15
Benefits:Excellent hourly rate

Company:
My client are a global specialty pharmaceutical and medical device company dedicated to improving patient health through innovative therapies and technologies. Their Blanchardstown campus in Dublin serves as a key hub for advanced manufacturing and global R&D, delivering high-quality medical devices to patients worldwide. With a strong commitment to operational excellence, regulatory compliance, and continuous innovation, Mallinckrodt offers an inclusive, collaborative work environment where employees can make a real impact.

The Role :
The Device Engineering Project Manager will be an engineering professional, responsible for leading technical projects (e.g. new product development and sustaining engineering) through a matrix of cross functional groups. Leads and delivers significant projects as a project management expert. Responsible for the strategic alignment, development and execution of projects that contribute to the Device Engineering group. Provides guidance on activities related to tactical projects, business needs and technological advances in the medical device sector. Will be responsible for project planning and management along with all activities needed for product development projects in accordance with design controls. Develops mechanisms for monitoring project progress and for intervention and problem solving through collaboration with other technical team members. Ensures project results meet requirements regarding technical quality, reliability, schedule and cost. Solves technical and nontechnical problems throughout the life of the project. Provides timely and accurate information and status updates to project sponsors, end users and management. Participates in budget development and evaluating how project plan changes impact cost and schedule

Role Functions:

• Provides leadership and centralised management for the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.
• Competent in making difficult decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders
• Manages and is responsible for all phases of project execution including stage gate reviews, design reviews, etc.
• Develops methods, procedures and metrics for projects (scope, schedule, quality and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope
• Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained
• Responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost and customer expectations are met. Maintains a clear focus on life cycle costs
• A technical / engineering background in new product development and sustaining engineering within the medical device sector.
• Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.

• A minimum of 4 years’ experience and a proven track record in:
• Applying project management tools to manage New Product Development Programs
• Applying project management tools to manage Sustaining Engineering Projects
• Building, managing and maintaining business partnerships
• Applying knowledge of ISO standards and FDA Design Control regulations
• Experience in development of complex sophisticated software controlled electromechanical medical devices with verification & validation activities is a plus.
• Experience in development of complex sterile disposable medical devices including plastic injection molding, extrusion and assembly methods is a plus
• Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus
• Degree and / or Masters in engineering or technical field with 5+ years of new product development (medical device engineering) and/or 5+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment.
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals
• Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.
• Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.