Project Manager

Pay : $67/hr

Onsite- Sunnyvale, CA

Overview:

The Program Manager – Project / Program Management will be responsible for the overall direction, coordination, implementation, execution, control, and completion of specific projects within a medical device and/or molecular in-vitro diagnostic company with the objective to deliver projects/programs on time and budget that meet business objectives and customer needs.. Experience in leading teams and complex project management will be highly valued.

Responsibilities:

Management of Projects

• Lead the planning and implementation of Market Expansion/Protection on-market project(s)
• Manage and lead discussions with cross functional stakeholders to ensure alignment and effective decision- making
• Facilitate the definition of project scope, goals, and deliverables
• Define project tasks, dependencies, and resource requirements
• Identify, prevent, manage, and escalate risks
• Develop and manage full scale project plans including project tasks and resource requirements
• Manage Design History File. Meeting Minutes; Risk Management Files, and project documentation
• Track project deliverables using appropriate Project Management tools
• Provide direction and support to project teams
• Implement and manage project changes and interventions to achieve project outputs
• Project evaluations and assessment of result
• Maintain/mange project intranet Sharepoint sites

Organizational Development

• Participate in development and continuous improvement on best practices for project execution and talent development for PMO
• Participate in strategic initiatives to strengthen competencies across PMO
• Contribute to improvement and implementation of cross functional internal processes
• Support implementation of good / industry standard project management and processes
• Sets objectives to align with broader organizational goals and breaks down objectives into appropriate initiatives and actions. Stages activities with relevant milestones and schedules and ensures on time delivery of projects within budget constraints. Anticipates and adjusts effective contingency plans.
• Able to manage complex projects and situations, by asking the right questions, acquiring data from all relevant sources and considering risks and benefits to solutions. Understands meaning and implication of key financial indicators and uses financial analysis to generate, evaluate, and act on strategic options and opportunities.

Qualifications:

• Bachelor's degree is required or higher. Life Sciences, Molecular Biology, Engineering and/or a technical discipline
• 3 years of direct work experience in a project management capacity
• 3 years of work experience in biology, engineering, or related fields

Preferred Qualifications:

• Medical device and/or In Vitro Diagnostic experience
• Experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003. Has working knowledge of quality documentation management systems within a regulated branch
• PMP or PgMP certification
• MBA or Strategic Program management
• Understanding of assay product development lifecycle