TRAINERS PROFILES

Norbert Leinfellner
Vice President Engineering / INOGEN

Special Guest Speaker
Director, Head of Program & Portfolio Management
Extensive experience managing new product development from feasibility to commercialization and post-launch monitoring of Medical Device (Class I, II and III), Pharmaceutical and Drug-Device combination products
• Change Agent and Process Improvement Leader
• Diversity of business experience – Technology Consulting, Fortune 100 Multinational & growth Start-up
• Leadership skills – Mentoring direct reports, Leading globally distributed cross-functional teams
• Comprehensive experience with Regulatory Filings:, INDs, NDAs, MAAs, 510Ks, PMAs and Audits
• Extensive product development experience under ISO 13485, QSR820.30, IEC 62304, IEC 60601, Risk Management, ISO 14971, Human Factors/Usability, GMPs