Intuitive-posted 4 months ago
Sunnyvale, CA
Computer and Electronic Product Manufacturing

The Senior Project Coordinator will help complex, cross-functional product development programs within Advanced Engineering. This role ensures timely execution of deliverables across subsystems including Instruments, Vision, Software, and Clinical, with a focus on regulatory and clinical readiness. The coordinator will drive operational efficiency, facilitate governance, and help logistical and tactical workstreams as well as strategic initiatives such as V&V deliverables and regulatory submissions.

  • 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
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