Project Manager

Organization: 
Cepheid - US
Job Location: 
Sunnyvale, CA
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 project
- 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

Education and Experience
- Bachelor's degree is required. Bioengineering, Biomedical engineering, and/or a technical discipline is preferred.
- 2-3 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 preferable
- qualification in project management or equivalent
- knowledge of both theoretical and practical aspects of project management
- knowledge of project management techniques and tools
- knowledge of quality documentation management systems
- direct work experience in project management capacity
- proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003
- proven experience in people management
- proven experience in risk management
- proficient in project management software

Key competencies
- critical thinking and problem solving skills
- planning and organizing
- decision-making
- communication skills
- influencing and leading
- team work
- negotiation
- conflict management
- adaptability

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