Sr Medical Device Program Manager
920 Winter St Greater Boston Area, Massachusetts 02451
Position: Sr Med Device Program Manager
Location: Greater Boston Area
Type: Contract to Direct Hire
Duration: 6 months to start
Interview Expectations: Phone and In Person preferred
Required: program manager, med device
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Has wide-ranging experience, and uses professional concepts in developing resolution to critical issues and broad design matters.
- Conducts detailed project planning and directs ongoing process to review and assess impact of changes to project. Determines potential options and ensures appropriate escalation, selection, and approval of decisions.
- Leads process to recommend options to adjust project priorities and plans to optimize resources and manage program/project risk.
- Leads multiple complex programs/projects and facilitates activities of all cross-functional teams to ensure that predetermined specifications and timelines are met.
- Mentors and leads project managers to ensure successful completion of projects to the satisfaction of the stakeholders. Develops and coaches project managers to increase their knowledge and skill levels.
- Establishes an efficient project reporting and program tracking system.
- Leads the application and continuous improvement of project management for all projects. Provides appropriate project management processes, methods, techniques, and tools and is able to elaborate and implement these according to the project’ s requirements.
- Leads project resource scheduling and oversees overall resource scheduling activities.
- Assigns cross-functional resources in collaboration with functional managers and holds them accountable for task and outcome completion.
- Leads cross-functional project team meetings and discussions ensuring appropriate participation, team focus on objectives, and documentation and communication of agreements and conclusions.
- Manages risk assessment and mitigation process for assigned projects.
- Directs issue tracking and resolution for assigned projects.
- Establishes communication plans for projects and ensures adherence to those plans while maintaining appropriate communication with all project constituents and stakeholders.
- Responsible for driving management activity and reporting on assigned projects, including gate reviews, steering committees, review boards, escalations, and decisions.
- Ensures adherence to established project management methodologies and best practices.
- Provides assistance to other staff with complex tasks that require considerable judgment and initiative.
- May escalate difficult/complex issues to supervisor/manager for resolution, as deemed necessary.
- Mentor other staff as applicable.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Complies with regulatory and FDA requirements, including GxPs and relevant standards. Assists in the creation and modification of policies and procedures.
- Assist with various projects as assigned by a direct supervisor.
- Other duties as assigned.