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Job Details

The Sr. Project Manager is responsible to plan, execute, manage risk, manage critical path and commercialize NPI and large sustaining projects according to strict deadlines and within budget. This includes engaging resources and coordinating the efforts of team members, third-party organizations and the client in order to deliver projects according to plan. Accountable to create project team governance to engage cross functional accountability of costs, schedules, scope, resources and track risks of projects.

Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Responsibilities/Essential Duties:

• Analyze project risks and identify their impact while developing mitigation strategies, identify and manage critical path, ensure appropriate project level definition across all stake holders and manage the project from concept to commercialization
• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.
• Manages day-to-day operational aspects of a project and scope. Complies with the Stage Gate Process quality system and helps to enforce standard operating procedures (SOPs). Escalates appropriately when required.
• Mitigates team conflict and communication problems. Escalates appropriately when required. Motivates team to work together in the most efficient manner.
• Leverages project management tools to assist in the development of and adherence to a schedule and reporting status.
• Own and create appropriate levels of governance to ensure alignment and clear objectives
• Accountable for product compliance to design history file, regulatory standards, and QMS procedures
• Keeps track of lessons learned and shares those lessons with team members

Experience Details:

• 5 plus project management leading medical device development.
• Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems
• Technical project management in software and hardware product development

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