Position Summary:

Project Coordinator I provides support to the management of new and existing programs and products at BioFire Defense. Project Coordinators are responsible for the implementation and maintenance of FDA/ISO regulated Medical Devices, and associated technologies and processes. Responsibilities include contribution to project plan execution and documentation, oversite of project resources, project timelines, and deliverables. 

Project Coordinators are expected to collaborate with development team(s), project managers, and operations teams to facilitate the development and implementation of design documentation and procedures according to internal Standard Operating Procedures and applicable FDA and ISO 9001/13485 regulations.

Principal Job Duties and Responsibilities:

1. Perform all work in compliance with company policy and within the guidelines of BioFire Defense's Quality System.
2. Facilitate project meetings, document action items and key decisions.
3. Draft project proposals, design documents, schedules, presentations, technical reviews.
4. Work collaboratively with project managers, area managers, and project stakeholders.
5. Use project scheduling tools to monitor and execute to project timelines.
6. Write, track, and manage change notices and change orders.
7. Independently manage small projects.
8. Proficient technical writing and oral skills.
9. Ensure consistent practices throughout all phases of the product life cycle.

10. May be required to obtain and maintain a DoD Personnel Security Clearance

     

Experience: 

• 3+ years of project coordinator/management
• Medical Device experience is preferred but not required
• Familiar with Quality Management System requirements and FDA/ISO regulations
• Experience with contracts and government operations is a plus
• Experience working in regulated medical device manufacturing environments