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Senior Device Project Manager
Ref No.: 18-16482
Location: South San Francisco, California
CANDIDATES MUST HAVE HANDS ON EXPERIENCE WITH MEDICAL DEVICE OR COMBO PRODUCTS
  • The Project Manager (PM) consultant will support 2 to 3 projects depending on the stage and complexity level of the program.
  • Project assignments will include pipeline, product care, technology and/or continuous improvement initiatives.
  • The PM will support project activities while onsite (5 days per week) with the flexibility to coordinate meetings and travel to accommodate global time zone interactions.
  • Limited travel is expected and any travel will require prior management authorization.
  • The PM is expected to enroll in the required training qualifications based upon business and project need.
The Project Manager (PM) in partnership with the Device Team Leader (DTL) will facilitate translation of the device strategy into a plan for execution at the Team level.
The Project Manager will lead execution of the device development plan within the agreed-upon constraints of scope, time and cost:

1) Facilitate effective planning with the Team to define "inspection ready” Design & Development Plans
2) Drive execution of Team activities to meet project and design control deliverables
3) Drive closure of Team actions to enable advancement to next stage through an effective Design Review process
  • The Project Manager will proactively drive planning and execution of the device strategy through the effective use of PM best practices and integration of Quality System Requirements (QSR) including design controls into Team activities.
  • This will involve oversight of project plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables.
  • The project plan will effectively integrate with the Technical Development Team (TDT) plan to meet schedule and budget requirements.
  • The Project Manager is responsible for promoting a collaborative team environment and maintaining positive team dynamics to enable on time execution.
  • A strong emphasis on effective meeting management, transparent team communication, efficient decision-making, proactive risk management, conflict resolution and problem-solving is required.
  • The Project Manager is responsible for applying best practices, driving consistency, and facilitating effective communication to enable optimum Device Team performance in a regulated environment. A variety of processes and tools will be used to manage the information flow & meetings (communication), team dynamics, budget, schedule, compliance and project risk management. With these processes the PM will enable the Team to effectively perform in meeting their deliverables.
Accountabilities:
  • Integration of key Device Team deliverables with other Team project plans
  • Project meets established deliverables and timeline within budget

Accountabilities
  • Integration of key Device Team deliverables with other Team project plans
  • Project meets established deliverables and timeline within budget

Scope of Activities:
  • Reporting & Time Tracking:
  • Meet regularly with manager to review project status highlighting challenges & remediation plans
  • Submit monthly status report highlighting Project goals, progress & noting any risks or delays to meeting milestones
  • Record time worked against relevant project codes in PlanSource time tracking tool
  • Collaboration and Teamwork
  • Assess team dynamics & lead team activities to enable high performing team environment
  • Establish relationships and network with other stakeholder teams and PMs
Communication:
  • Develop and adapt project communication tools (e.g. dashboard) to drive awareness of project progress & risks. Include external parties.
  • Facilitate timely project decision making, problem solving and conflict resolution
  • Act as Device Team Leader back-up as required for project communication "spokesperson”.
  • Participate in CMO and Partner meetings & integrate relevant outcomes into project plan.
  • Liaise with other teams and sub-teams to address cross-functional activities, issues & risks.
  • Process Management

Project Planning & Execution:
  • Schedule: Develop, monitor, and control the detailed Device Team project schedule.
  • Oversee project plan execution for deliverables and milestones
  • Lead project deliverable integration with Teams associated with the product deliverables
  • Meetings: Facilitate Device Team meetings with meaningful desired outcomes, minutes & follow up
  • Budget: Actively plan and monitor Device Team FTE & Device PVC needs

Knowledge Management:
  • Ensure team access to all relevant project information
  • Manage the uncontrolled document repository for the project (e.g. Project History File).
  • Share lessons learned at appropriate points to a broader audience
  • Project Issue & Risk Management: Facilitate resolution of Team issues and conflicts
  • Compliance
  • Direct creation & execution of the project plan
  • Facilitate and maintain the Design & Development Plans with Device Team input
  • Facilitate Design Review process to enable advancement to the next stage
  • Support internal and health authority audits as required
Qualifications:
  • B.S. or B.A. degree (preferably in engineering) and 5 to 10 years relevant business and/or technical experience in the medical device or pharmaceutical industry preferably from a multi-site global company.
  • Experience in combination products considered an asset.
  • Qualified candidates must have a proven track record leading development projects and ability to apply project management methodologies and Design Control requirements.
Other job requirements include:
  • Demonstrated development & commercialization experience & knowledge of medical devices
  • Knowledge of Health Authority requirements applicable to pharmaceutical & medical devices
  • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, ever-changing, team-based environment.
  • Excellent written and verbal communication, listening, negotiation, presentation, organizational and relationship-building skills required.
  • Demonstrated proficiency with Google, Microsoft Office, WebEx, Visio software tools
  • At least 5 years Project Management experience - PMP certification considered an asset
  • Onsite 5 days per week - Some travel expected dependent on project assignment
M-F 8/5