What are the responsibilities and job description for the Project Manager (Medical Device Experience) #0465 position at Enhanced Compliance?
Project Manager (Medical Device Experience) #0465
Location
Marlborough, MA, 01752, United States
Job Category
Project Management, Medical Device
Employee Type
Contractor or FT Employee
Required Degree
4 Year Degree
Travel
15%
Minimum Experience
7 Years
Description
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)
Additional Information
Type Of Work
Hybrid