0090 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 performance metrics.
- Project Management: Project planning, scheduling, tracking team deliverables and actions, facilitating team decisions, risk management, resource and cost forecasting, meeting management, regular project status communication.
- PMP certification.
- Software tools: Google, Microsoft Office, WebEx, Visio, Project.
- 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.
- B.S., B.A or advanced degree, preferably in Chemistry or Biochemistry, or the equivalent.
- Minimum 8 years Project Management experience.