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Senior Project Coordinator

Job Post Index 239AFA-Sy##
Location Sunnyvale, CA
Description: Description
  • 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
  • Support/Lead 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
  • Strong collaboration and direct participation with Regulatory during final preparations for submissions
  • Solid understanding 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
Skills: Qualifications
  • Bachelor’s Degree required.
  • Masters degree preferred.
  • Familiar with software terminology and software development lifecycle activities and deliverables
  • High familiarity tracing documentation in accordance to medical device design control requirements
  • 5+ years of directly related experience desired; medical devices experience strongly preferred
  • Good organizational and investigative skills; proactive problem solving
  • Excellent verbal and written communication skills
  • Ability to quickly switch between many different projects
  • 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
  • Specialized training in a discipline such as computers and/or planning and scheduling

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