For a hi-tech company developing medical devices, with offices in the north Sharon.
This position requires leadership of cross functional team in a multi-site organization.
The Project Manager is responsible for the planning, scheduling and execution of activities within the framework of FDA Quality System Regulations and under FDA Design Controls.
Responsibilities may include the following and other duties may be assigned:
Responsible for project planning and execution to ensure timely completion of tasks, in compliance to the Product Development Process and overall Quality Management System.
Overseeing multiple projects and their dependencies
Responsible for project risks identification and provides mitigations.
Interfaces with all functional areas affected by the project including R&D, Engineering, Manufacturing, Quality, Regulatory, and as needed end users, distributors, and suppliers.
Manages and reports on project status and budgets; manages schedules and prepares status reports (written and verbal) for PMO, Leadership team and Executive Management updates.
Communicates and engages with stakeholders to ensure successful delivery of the project in alignment with all stakeholder needs and expectations.
Monitors the effectiveness and performance of the project and project team and facilitates the development of contingency plans and proposes corrective actions as required.
Bachelor’s degree in Industrial \ Mechanical \ Electrical \Bio-Medical Engineering or Science related field
5+ years of experience with multi-disciplinary projects management
Profound manufacturing and quality background
Knowledge of ISO13485 and relevant Medical Devices Industry Standards
Quality System experience in Medical Devices / Pharmaceutical industries
MS Project Online and MS Office proficiency
MS Excel proficiency
Ability to manage, operate and be effective in a matrix organizational structure
Fluent verbal, writing and reading English proficiency
Biotech/medical, High Tech
Medium (50 - 150)