Device Engineering Project Manager

Device Engineering Project Manager
Mallinckrodt Pharmaceuticals Ireland Ltd, is an international Pharmaceuticals and

Medical Device manufacturer that has been managing complexity and improving
lives since 1887 and distributing high quality drug delivery systems since early 2000.
We offer a rewarding work environment with global opportunities while maintaining
an employee-focused atmosphere. We are currently searching for a dynamic
Technical Project Manager to join our Global Device Engineering (GDE) team in
Dublin.
Reporting to the Senior Director Device Engineering the Technical Project Manager
will be an engineering professional, responsible for leading technical projects
through planning, scheduling, budget management, resource management for
change control and stage gate projects in alignment with the department’s SOPs in a
matrix of cross functional groups. Leads and delivers projects as a project
management expert. 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. Integrates with the project teams and facilitates
discussions on technical and nontechnical problems throughout the life of the
project. Oversees and coordinates work performed by outside contractors. Provides
timely and accurate information and status updates to project stakeholders and
management. Participates in budget development and evaluating how project plan
changes impact cost and schedule.
Main Responsibilities:
• 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.
• Leads the project team members in using established PM tools and techniques to
stay within authorized budget limits and achieve the overall project and
organizational objectives.
• Competent in conducting risk assessments for technical and project related issues
and developing mitigation plans to ensure project schedule and costs are
maintained.
• Innovator and forward thinker. Leads and contributes to the development of GDE
organisation thru innovative thinking and application of technical knowledge.
• Develops methods, procedures, and metrics for projects (scope, schedule, quality,
and cost) and reporting. Monitors and controls implementation plan in accordance
with defined scope.
• 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 Medical Device product development and
sustaining engineering within the medical device sector.
• Fosters an environment of innovation in others, integrating experiences from

multiple disciplines to develop solutions that meet the business objectives.
• An understanding of medical device regulations including FDA standard 21 CFR

Parts 820, design controls, ISO13485, regulatory audits and international
environmental regulations. Experience and track record of success in the
development of 510K/PMA regulated medical products required.
Job Requirements:
• A minimum of 3 years’ experience and a proven track record in:
o Applying project management tools to manage Product Development Projects
o Applying project management tools to manage Engineering Projects
o Building, managing, and maintaining business partnerships.
o 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.
• BS in engineering or technical field with 3+ years of product development (medical

device engineering) and 3+ years of applicable project management experience in
medical devices, healthcare, or pharma development environment.
• Possesses interpersonal skills to negotiate and reconcile differences, while

optimising 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.

Device Engineering Project Manager

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Device Engineering Project Manager

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Device Engineering Project Manager

Mallinckrodt Pharmaceuticals Ireland Ltd, is an international Pharmaceuticals and

• Fosters an environment of innovation in others, integrating experiences from

• An understanding of medical device regulations including FDA standard 21 CFR

• Experience in development of complex sophisticated software controlled

• Experience in development of complex sterile disposable medical devices including

• Experience in outsourced medical device manufacturing, manufacturing

• BS in engineering or technical field with 3+ years of product development (medical

• Possesses interpersonal skills to negotiate and reconcile differences, while

• Excellent written and verbal communications skills with strong competency in MS

• Certification in Process Excellence (Green Belt or Black Belt) or project

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