Project Manager

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The Project Manager will be responsible for the overall direction, coordination, implementation, execution, control and completion of specific medical device, molecular in-vitro diagnostic projects ensuring consistency with company strategy, commitments and goals.

 

  • Lead the planning and implementation of multiple projects
  • Facilitate the definition of project scope, goals and deliverables
  • Define project tasks and resource requirements
  • Develop full scale project plans
  • Manage Design History File. Meeting Minutes; Risk Management Files, and project documentation
  • Manage project resource allocation
  • Plan and schedule project timelines
  • Track project deliverables using appropriate tools
  • Provide direction and support to project team
  • Constantly monitor and report on progress of the project to all stakeholders
  • Present reports defining project progress, problems and solutions
  • Implement and manage project changes and interventions to achieve project outputs
  • Project evaluations and assessment of results

Requirements
  • Bachelor's degree is required. Bioengineering, Biomedical engineering, molecular biology and/or a technical discipline is preferred. Or, equivalent combination of education and experienceto perform at this level.
  • 3-4 years of direct work experience in a project management capacity, including all aspects of clinical development, plan execution and product launch
  • Experience with launching a medical device or and In Vitro Diagnostic product
  • Qualification in project management or equivalent
  • Knowledge of both theoretical and practical aspects of project management
  • Knowledge of project management techniques and tools
  • Direct work experience in project management capacity
  • Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003, FDA regulations
  • Proficient in MS Project, Office, and Outlook.

Key competencies

  • Superior interpersonal and communication skills, both written and verbal
  • Team builder and team player
  • Strong analytical and problem solving skills
  • Demonstrated cross-functional leadership
  • Decision-making
  • Influencing and leading
  • Negotiation
  • Conflict management
  • Adaptability

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How to Apply

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