Senior Project Coordinator

Intuitive • Sunnyvale, CA

168d

About The Position

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.

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

Nice To Haves

• 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

Responsibilities

• 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

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree