Ningze Sun

About Ningze Sun

Visionary and engaging project leader with track record of launching innovative life-saving diagnostic and surgical medical devices to better serve patients and physicians. PROJECT MANAGEMENT | STRATEGIC PLANNING 15 years of project management experience in the medical device industry.Certified PMP.Experience of lead, influence and collaborate cross-functionally to achieve shared goals.Experience of working with all phases of the product development lifecycle including concept evaluation, feasibility, design verification, validation, and commercialization of new medical devices.Strong influencing and change management skills to coalesce conflicting views and drive alignment.Excellent organizational skills and ability to work in a demanding environment while motivating core and extended project teams.Excellent communication (written, verbal) skills and executive presence. • Strategic planning • Product road map planning • Full product development cycle • Project planning • Technical leadership • Product commercialization • Project management best practice • Project resource planning and schedule planning • Financial modeling & analysis • Build highly effective teams • Communication across organizations • Resource and budget management • Stakeholder management • Risk management & issue management • Change management • Critical thinking & problem solving • Quick Learner, team development • PMO office best practice • Medical device and life sciences R&D • Medical device software development

Experience

1. Senior Technical Program Manager - R & d at Genmark Diagnostics (Roche)

   Roche

   Sep 2024 — Present · Carlsbad, CA, US

   Lead technical program.

Education

• UMN Carlson School of Management

  Master of Business Administration (MBA), Business Administration and Management, MILI

• Zhejiang University

  Master, Mechanical

• University of Minnesota

  Master of Engineering (M.Eng.), Mechanical Engineering

Skills

• R&D
• Biomedical Engineering
• Design of Experiments
• Manufacturing
• Tuv
• Six Sigma
• Product Launch
• Spc
• Design for Manufacturing
• Cfd
• Iso 13485
• Management
• Fda
• Mechanical Engineering
• Product Development
• Tuv Submission
• Design Control
• 510k Submission
• Design Verification and Validation
• Validation
• Cross-Functional Team Leadership
• Iso 14971
• Fmea
• Quality System
• V&V
• Project Management
• Minitab
• Medical Devices
• Capa