Senior Project Coordinator

Intuitive•Sunnyvale, CA

10d

About The Position

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!

Requirements

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

Responsibilities

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