Project Manager (Medical Device Experience)

Who We Are:

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role:

The Project Manager will be responsible for the coordination, implementation, execution, control, and completion of the program/project. The Project Manager will support the Centralized Program Management Office (CPMO) activities of the organization as below:

Project and Program Management

• Standardize use of CPMO project management tools, techniques, and activities across all client sites
• Provide updates and project visibility to the executive management/leadership team
• Support CPMO policies, processes, templates and tools development
• Responsible for the overall project management specifically focused on ensuring overall client satisfaction quality of delivery, and performance of the engagement
• Manage dependencies across multiple projects and track benefits
• Manage risk to projects, ECI, and its affiliates.
• Create project reporting metrics for each client/project.
• Develop and maintain a detailed Project Timeline for the activities included in the scope of the project
• Develop a resource Plan, and facilitate resource loading (when, how many, and necessary skills) to successfully execute the project
• Develop a workflow for project optimization
• Reduce redundancy by being a central point for lessons learned, templates, and best practices.
• Utilizes appropriate project management tools and techniques to drive project execution
• Achieves operational objectives by contributing information and recommendations to strategic plans and reviews; preparing and completing action plans; implementing company core values; resolving problems; completing audits; identifying trends; determining project improvements; and implementing change.

Resource Management

• Manage resources for projects by managing project staffing, providing earned value management, tracking projects, delivering training and mentoring team members, and assigning roles and responsibilities.
• Identify consultant value, opportunities to increase consultant utilization, etc.
• Provides feedback regarding consultant performance.
• Regularly review resource levels against timeline elements and adjust accordingly
• Facilitate project-specific training and onboarding of team members from deployment through the completion of the project

Client Management

• Manage escalation(s) of concerns, delays, observations, watch-outs through agreed-upon escalation process
• Facilitate mitigation, where possible, of any project delays
• Identify client grievances to be addressed immediately
• Regularly update client and company management as to the status of the project and/or project elements for which the consultant is responsible
• Immediately advise the client when issues impacting the project timelines and/or compliance are discovered
• Facilitate face-to-face project meetings as appropriate
• Ensure overall client satisfaction.

Technical Management

• Provides guidance to team resources in areas of R&D, Manufacturing, Quality, and Regulatory Compliance.
• Collaboration on Strategy Development, Deployment, and Execution
• Provide project engineering and project management support.
• Act as client council for strategic guidance including technical expertise and best practices
• Maintain traceability by providing the function for managing documentation, project history, and organizational knowledge.
• Produce and deliver new industry trends, regulatory updates, techniques, etc. to resources

What We Look For:

• Bachelor’s degree
• 10 years of experience in the medical device industry in the areas of manufacturing, development, or quality leading technical projects with increasing responsibilities
• A clear understanding of key medical device regulations such as 21 CFR 820 and ISO 13485 including all aspects of a quality management system.
• Strong interpersonal, communication, facilitation, and presentation skills
• Strong analytical and problem-solving skills
• Understanding of project leadership aspects such as management of deliverables, setting of timelines, and status updates to management
• Excellent organizational skills with demonstrated ability to complete projects on time and to the satisfaction of the customer
• Demonstrated ability to establish and maintain effective relationships and partnerships with key customers/stakeholders/clients
• Proficient computer skills including Microsoft Office and Microsoft Project (or similar)