Job Title

Senior Project Manager, Global Device Engineering

Requisition

JR000015171 Senior Project Manager, Global Device Engineering (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

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

Job Description

Provides leadership and centralized 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 / program 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 R&D 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 new 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.

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.

Minimum Requirements

Education / Experience / Skills

A minimum of 10 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 10+ years of new product development (medical device engineering) and/or 10+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment.

Strong experience in people management and organisational development / alignment in line with budget and business needs

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.

Organizational Relationship/Scope:

This role is a leadership position with the Global Device Engineering function and as such will have significant responsibility for the management of technical programs of high strategic importance. The role will demand significant interaction with all other functions (QA / RA / Clinical / Ops / Finance / Commercial) and will be the primary interface for the organization on major project updates.

A breakdown of focus areas withing GDE is outlined below:

New Development project planning & management activities 30 %
Sustaining engineering support & manufacturing transition project activities 10 %
Coordination and management of engineering design control documents 10 %
Organisational leadership / people management 30 %
Coordination of external development/engineering partnerships 20 %

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