Team

Sandra Regnell

Principal Consulting Engineer – R&D, Quality, Manufacturing

 

 Sandra Regnell has twenty-nine years of experience in the Medical Device and Combination Product industries. Sandra started her career in the Silicon Valley performing R&D engineering, project and functional management for medical products in the cardiovascular, electrophysiology, needle and parental feeding tube markets. After moving to Southern California and Seattle, Sandra also worked in both the combination device market as well as the device market, performing Quality, Sustaining and R&D activities. Sandra has worked in all phases of the medical device life cycle and is skilled in creating, managing, and remediating design history and risk management files. Sandra enjoys solving complicated problems and is a creative, out of the box thinker. She loves strategy and is gifted in making order from chaos by creating and using business processes and connecting people to work together to achieve goals. 

Academic & Professional Qualifications:
  • BSME, Santa Clara University, Santa Clara, California
  • US Patent 2005/0149097 Transseptal Needle
Training, Quality Systems, and Specialties:
  • AAMI Human Factors
  • AAMI EO Sterilization
  • Biological Safety Specialist – NAMSA
  • Design Control
  • Design Verfication
  • Process Validation
  • Complaint Handling
  • CAPA
  • Root Cause Analysis
  • ISO 13485
  • ISO 14971
  • 21 CFR 820