
Senior Project Coordinator
- Sunnyvale, CA
- Permanent
- Full-time
- Work with Program Managers tracking project plans, risk management plans, documentation, and tasks
- Succinctly monitor and report status: project milestones, documentation, action items, and deliverables
- Review projects for variances to schedule
- Proactively organize efforts to alleviate bottlenecks and speed execution
- Coordinate activities defined by the Program Manager
- Help/Drive meetings including taking minutes and tracking action items
- Initiate and implement business process improvements when gaps are identified
- Manage milestones and activities across Development, Quality Assurance/Test, and Operations members
- Closely track Verification and Validation protocols and reports for Regulatory submissions
- Exceptional partnership and direct participation with Regulatory during final preparations for submissions
- Solid comprehension of Quality Systems or Design Controls for Medical Devices
- Agile (ACCS) originator experience initiating ECOs
- Setup Design History File (DHF) structure; work with team to ensure DHFs are updated and accurate
- Coordinate design and phase gate reviews - Assembling presentations, checklists, and action items
- Liaison with Document Control and ECO Change Control Board (CCB) to ensure timely approval
- Familiar with software terminology and software development lifecycle activities and deliverables
- High familiarity tracing documentation in accordance to medical device design control requirements
- Bachelor's Degree required. Master's degree preferred.
- 5+ years of experience in project coordination or program management within a technical or regulated environment, med device experience is highly preferred
- Familiar with waterfall and SCRUM project management
- Proficient in Word, Excel, PowerPoint, Project, Smartsheet, or other similar tools
- Proficient in ALM tools (such as MKS or Polarion), Oracle/Agile, and JIRA
- Good organizational and investigative skills; proactive problem solving
- Excellent verbal and written communication skills
- Ability to quickly switch between many different projects
- Specialized training in a discipline such as computers and/or planning and scheduling