Project Coordinator

Job Description

Primary 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 deliverables
• Support 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 requirements
• Setup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs.
• CAPA tracking/closure support.