Michelle Wu

About Michelle Wu

Learner - Achiever - Analytical - Harmony - Futuristic -A leader with nearly 20 years in the medical device and biopharmaceutical industries, with roles in process development, manufacturing support, quality, and executive leadership. With an eye for organizational excellence and continual process improvement in a risk-based and value-added manner. I value a collaborative and diverse, equitable, and inclusive environment, believing that diverse perspectives lead to the best ideas, more cohesive teams, and better results.Key Experiences and Characteristics: • Human-centric medical technology development, quality, and manufacturing operations • Consultancy and service organizations• Organizational growth• Leadership and team building• Collaborative strategic planning and execution• Risk-based and value-added operational improvement• Mindful mentorshipKey Achievements• Human-centric medical technology and medical device development: Successfully guided and oversaw 50+ teams through various phases of human-centered medical device and technology and IVD development, from initial engineering, detailed engineering, design verification, through transfer to manufacturing and commercialization that met clients’ business needs.• Leadership and team building: Operated the engineering and design team during a year of 40% revenue growth and addition of 80 staff in an organization of ~200 full-time staff. Built up capabilities and leadership across Engineering and Design, Quality, and integrated 3 US offices.• Strategic planning and execution: Directed, executed, and supported corporate long- and short-term initiatives and plans including operation site integration and strategy, culture definition, organizational structure, enterprise risk management, capabilities and business tools and processes.• Operational Efficiency: Implemented tools, processes, and management for operational oversight, resource management, and quality management. Decreased administrative burden in various areas by 50% and decreased non-value-added time for resourcing by 25%.• Mentorship and diversity: Championed a Diversity Council, Women’s affinity group, and regular outreach to expose youth to STEM/STEAM.A current board member and Development Committee chair for Community MusicWorks, a non-profit organization based in Providence, RI. Its mission is to create cohesive urban community through music education and performance that transforms the lives of children, families, and musicians.

Experience

1. Mass Challenge Judge and Mentor

   Masschallenge

   May 2022 — Present

Education

• Massachusetts Institute of Technology

  MSCEP

• University of Michigan

  BSE

Skills

• Cross-Functional Team Leadership
• Root Cause Analysis
• Validation
• Quality Assurance
• Design Control
• Quality System
• V&V
• Testing
• Fmea
• Product Development
• Design of Experiments
• Manufacturing
• Fda
• Iso 13485
• Medical Devices
• Capa
• Quality Control
• Gmp