Primary Function of Position: We are seeking a Senior Project Coordinator to support the Program Management team focused on new product development. The Senior Project Coordinator will help execute product development and process-specified activities to ensure compliance with established Design Control and Project Management processes, with a strong focus on collaboration with cross-functional groups. Need to be proactive, a strong communicator, key influencer, relationship builder, detail-oriented, and have investigative skills. This is the position for you if you love to help teams thrive and exceed expectations! Job Requirements: Work with Project Managers defining and tracking Project Plans, Risk Management Plans, work breakdown structure, project budget, and task definitions Monitor and report project status for project milestones, documentation, and deliverables Review projects for possible interference/variances to schedule and/or specifications: proactively organize efforts to alleviate bottlenecks and speed execution. Coordinate and follow up on activities of team leader / program manager; represent the team and assigned projects where necessary Support/Lead team meetings including taking minutes and tracking action items. Initiate, develop and implement departmental, process related improvements Closely track Verification and Validation protocols and reports for Regulatory submissions Work all across New Product Development on milestone activities including ECO submissions, reviews, and closure Coordinate design reviews and phase gate reviews– Assembling presentations, Checklists, action items, etc. Solid understanding of Quality Systems or Design Controls for Medical Devices Setup Design History File (DHF) structure; work with project team to make sure document owners update documentation and save to DHFs Maintain business review packages and business records for projects assigned Strong collaboration and direct participation with Regulatory during final preparations for submissions Track Issues, coordinate last minute changes Liaison with Document Control and follow-up with approvers of change orders to ensure timely review and approval Manage lab resources (hardware, software, instruments and accessories) and monitor allocations based on the needs and schedule of various competing projects. Support historical investigations including audit requests, CAPA, and process improvement projects CAPA tracking/closure support
Skills, Experience, Education, & Training: Bachelor’s Degree required. Masters degree preferred. 5+ years of directly related experience desired, medical devices experience strongly preferred Additional specialized training in a discipline such as computers and/or planning and scheduling Familiar with waterfall, SCRUM, and hybrid project management techniques Should be highly proficient in Word, Excel, and PowerPoint Active user of Microsoft Project or other project planning and tracking tools Nice to Haves: Medical Device is a huge plus Good organizational and investigative skills Proactive problem solver Excellent verbal and written communication skills Ability to switch between many different projects quickly Passion for rapidly executing projects creating robust and reliable products Familiar with waterfall, SCRUM, and hybrid project management techniques Should be highly proficient in Word, Excel, and PowerPoint Active user of Microsoft Project or other project planning and tracking tools Proficiency in Oracle/Agile and SAP a plus
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal 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. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export licens