9328 Project Manager IV
Manage teams and projects of increased complexity.
Develop realistic project plan/schedules.
Define, oversee and track Development Team’s progress in meeting milestones and deliverables.
Partner closely with Device Team Leader (DTL) to define and execute the device/technology strategy and facilitate team meetings with key stakeholders to drive sharing of information, efficient decision-making, issues resolution, risk mitigation and team member engagement.
Ensure device/technology strategy is integrated with Technical Development Team (TDT) plan and aligns with overall Lifecycle Team (LCT) strategy.
Analyze and understand the critical path activities and ensure team members are aware of the interdependencies.
Connect with management to provide regular project updates on project status including risk mitigation plans and to escalate unexpected events impacting project schedule, budget and resources.
Monitor resource and project variable costs needed to execute Plan and work closely with TDT project manager to ensure budget is integrated with TDT plan in PlanSource.
Project Management: Project planning, scheduling, tracking team deliverables and actions, facilitating team decisions, tracking risks.
Resource and cost forecasting, meeting management, regular project status communication.
Software tools: Google, Microsoft Office, WebEx, Visio, MSProject.
Requirements: International standards (e.g. ISO 13485), federal regulatory compliances (e.g. FDA and EU), filings, relevant health authority regulations, Drug Development processes, Design Controls, GDP/GLP/GMP, Design History Files.
Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team based environment.
Highly organized and detail oriented.
BS/BA (Engineering/Science preferred) or advanced degree. Minimum 9 years project management experience.