Documentation Coordinator/Processor 1

Job Title:Project CoordinatorReports To: Manager, Design ValidationAt Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care.Primary Function of Position:• We are seeking a Project Coordinator to support software product development projects. The Project Coordinator will identify, track, and facilitate SOP requirements and activities to ensure Design Control and Computer Systems Validation compliance, including working with traceability and document database tools. A large responsibility is deliverable tracking and coordinating the writing and release of documentation during the design phase. Must be proactive, detail-oriented, and possess strong communication and time management skills.Roles & Responsibilities:• Work with Program managers and Design Validation Engineers in tracking activities, risks, and documentation• Monitor and succinctly report status: milestones, risks, action items, and deliverables• Review projects for schedule variances and mitigate them• Proactively organize efforts to alleviate bottlenecks and speed execution• Coordinate activities defined by the program manager and core team• Manage milestones and activities across Development, Quality Assurance/Test, and Operations members• Initiate and track ECOs in Agile (ACCS)• Import and manage documents and traceability in ALM systems (PTC Integrity / Polarion), significant data entry responsibilities• Set up Design History File (DHF) structure; work with team to ensure DHFs are updated and accurate• Liaison with Document Control and ECO Change Control Board (CCB)Skills, Experience, Education, & Training:• Minimum Bachelor's Degree required• Minimum 2 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• Solid understanding of Quality Systems or Design Controls for Medical Devices and SDLC• Proficient in Word, Excel, PowerPoint, Project, Smartsheet, or other similar tools• Proficient in ALM tools (such as MKS/PTC Integrity or Polarion), Oracle/Agile, and JIRA• Specialized training in a discipline such as computers and/or planning and scheduling• Data entry and traceability management experienceIntuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.