Team

Justin Schmidt

Consultant

Justin is a Systems Engineering leader with experience developing a broad range of medical devices and combination products.  He has effectively managed engineering teams across multiple time zones, executing strategies to improve communication and meet project goals and timelines.  Justin has led the development and integration of quality system procedures, ensuring the implementation of state-of-the-art processes.  He has a proven work ethic and high-level of performance to deliver valuable and sustainable results.

Academic & Professional Qualifications:
  • B.S. Biomedical Engineering, University of Wisconsin – Madison
Training, Quality Systems, & Specialties:
  • ISO 13485, 21 CFR 820.30
  • ISO 14971 Risk Management
  • IEC 60601
  • Scrum/Agile Development Methodologies
  • Product Development Tools and Training: DOORS, JIRA, MagicDraw, SysML