Project Coordinator

Job DescriptionPrimary Function of Position We are seeking a Project Coordinator to support the Program Management team focused on new product development. The Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Control and Project Management processes, with a strong focus on collaboration with cross-functional groups. Need to be proactive, a strong communicator, key influencer, relationship builder, detail-oriented, and have investigative skills. This is the position for you if you love to help teams thrive and exceed expectations!
Essential Job Duties Work with Project/Program Managers defining and tracking Project Plans, Risk Management Plans, work breakdown structure, project budget, and task definitions.Monitor and report project status for project milestones, documentation, and deliverablesSupport team meetings including taking minutes and tracking action items where necessary.Work all across New Product Development on milestone activities including ECO submissions, reviews, and closure.Liaison with Document Control and follow-up with approvers of change orders to ensure timely review and approval.Coordinate design reviews and phase gate reviews– Assembling presentations, Checklists, action items, etc.Closely track Verification and Validation protocols and reports for Regulatory submissions.High familiarity with tracing documentation in accordance with medical device design control requirementsSetup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs.CAPA tracking/closure support.
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