معرفی
Kristina K. Simmons serves as an Instructor in the School of Engineering at the University of St. Thomas, bringing over 24 years of medical device industry experience to her academic role. She concurrently holds the executive position of Vice President of Quality and Integration PMO at Medtronic's Cardiac Ablation Solutions Business, where she leads global quality strategy, compliance, and product reliability initiatives.
Her educational credentials include:
- Regulatory Affairs Certification (RAC)
- Master of Science in Manufacturing Systems, University of St. Thomas
- Bachelor of Science in Biology, Saint Norbert College
Ms. Simmons' professional expertise centers on Regulatory Affairs, Clinical Research, and Medical Device Product Development within highly regulated environments. Her work emphasizes leadership in quality systems implementation, product lifecycle management, and cross-functional team oversight across pre-market development and post-market surveillance phases. She maintains active membership in the Regulatory Affairs Professional Society (RAPS) and has held progressive roles spanning sales, clinical research, quality assurance, R&D, and regulatory affairs at Medtronic, Empi Medical, and MinRad Inc.
Her industry leadership encompasses driving global quality strategy, budgeting, and oversight for multinational teams while ensuring compliance with international medical device regulations. Ms. Simmons applies her extensive practical experience in regulatory science and medical device development to inform her academic instruction, though she is not currently scheduled to teach courses in Fall 2025 or Jterm 2026.
