This Sr. Analyst, Project Management position is an exciting opportunity to be a part of the growing Transcatheter Heart Valve organization. This is a project management position focused on medical device new product development projects. You will have a key role in owning the Product Development Process tools and templates; drive continuous process improvement and refinements across teams and company.
Assist in the management of projects in partnership with other project managers
Determines and discerns detailed requirements on mid-to-large scale projects to establish the project deliverables and develop the project management plan, and manage changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes
Leads the execution of tasks as defined in the project management plan and actively manage project risk.
Assesses project performance to monitor the progress of the project, identify and quantify variances, perform required corrective actions and communicate to all stakeholders
Establishes and coordinates team members and stakeholder relationships, expectations, and communications
Facilitate early identification of project risks and mitigation, and manage the risks and issues throughout the project schedule.
Manage and control changes from original scope for every project
Partner with project leads, cross-functional groups and other project managers to define/manage resource requirements to support project schedules.
Manage design reviews, design history files and project documentation for projects
Serve as conduit between project/team members in all cross-functional groups (e.g. Clinical, Marketing, Ops, Quality, R&D, Regulatory, etc.)
Establish and maintain project stakeholder relationships and communications
Be a Subject Matter Expert (SME) in business processes and lead efforts to optimize processes and systems
Apply project management methods and tools to every project
Manages project closure activities, including gathering lessons learned
Actively leads one or more Project Management Office (PMO) continuous improvement activities
Bachelor's Degree or equivalent related field 5 years hands-on experience managing mid-to-large scale projects. A Project Management Professional (PMP) Certification is preferred. Experience in medical device industry and R&D new product development is a plus. Experience using Critical Chain Project Management methodology is a plus.
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Extensive understanding and knowledge of principles, theories, and concepts relevant to managing mid to large scale project plans
Partner with project leadership on overall project scope and execution
Experience implementing risk and issue controls is strongly preferred
Experience with regulatory agency guidelines for medical device manufacturers is a plus
Ability to be flexible in a dynamic environment, adapt to new technologies and rapidly changing environment
Ability to proactively escalate issues to appropriate levels of management in the organization
Must have excellent verbal and written communication skills
Good leadership skills and ability to influence change
Excellent problem-solving, organizational, analytical and critical thinking skills
Excellent understanding and work experience with project budgets and financial management
Possess and display sound judgment; initiative; flexibility and detail-orientation
Ability to develop and maintain business and technical documentation
Self-motivated and frequently demonstrates initiative by going "above and beyond" performing what is required for the position
Demonstrates creativity to develop and implement innovative, thought provoking solutions and changes
Ability to drive collaborative project management process/tool improvements and implementation through training and metrics is a plus
Invests time in self-development/improvement Ex. higher education, project management certifications/credentials, participation in developing and implementing solutions in areas outside of normal responsibilities
Proficient with MS Project, Excel, Word, PowerPoint and Visio.
Edwards Lifesciences Corp