Cari Herman

About Cari Herman

Experienced professional with increasing responsibilities in technical management in regulated industries (FDA and FAA).Medical Device • Engineering Management / Program Management • Risk Management and Patient Safety • Post Market issue assessment / product containment (product recalls) • Quality Management Systems / Compliance • FDA Inspections under consent decreeAircraft/Aerospace • Software Program and Project leadership • Software Systems and Systems Engineering Management • Software Focused Process Management • Product Certification

Experience

1. Sr Engineering Manager

   Medtronic

   Mar 2021 — Present · Fridley, MN, US

   Responsible for the post-market activities associated with Medtronic\'s Targeted Drug Delivery (TDD) Systems*Managed a team of Program Managers and Risk/Reliability engineers responsible for the monitoring and evaluation of post-market issues. Supported individual growth/promotions, championed continued education, and community involvement.*Supported calls/interactions with implanting and managing physicians regarding questions related to the Infusion System products (drug pump, catheter, clinician programmer, patient programmer).*Served as Tiered Board Chair responsible for making containment and recommending field corrective actions. Presented issue evaluations and recommendations to Sr. Leadership for final product decisions.*Managed data and presented post-market metrics to Sr. Management during monthly Management Reviews*Responsible for representing TDD documentation and decisions in yearly internal and external regulatory (FDA, TUV) inspections in a consent decree environment.*Author/owner of Quality System post-market processes (ISO 13485, ISO 14971, 21 CFR 820).*Medtronic\'s Global Quality Functional Excellence Award recipient

Education

• Embry-Riddle Aeronautical University

  MS, Aeronautical Science

  1995 — 2008

• University of St. Thomas

  MBA, Marketing

• University of North Dakota

  BS

  1986 — 1991

• Cheyenne Aero Tech

  Certified Aviation Maintenance Technician (A&P Mechanic), Aviation Maintenance Technology

  1992 — 1993

Skills

• Fda
• Agile & Waterfall Methodologies
• Software Documentation
• Sdlc
• Product Development
• Engineering Documentation
• Integration
• Engineering
• Risk Management
• Software Certification
• Iso 13485
• Statistical Tools
• Ms Project
• Systems Engineering
• A&P
• Do-160
• Federal Aviation Regulations
• Process Management
• Engineering Management
• Strategy
• Maturity Models
• Agile Methodologies
• Airframe
• Do-178b
• Do-254
• Aircraft Systems
• Design Control
• Program Management
• Software Project Management
• Customer Management
• Powerplant
• Cross-Functional Team Leadership
• Engineering Change Control
• Testing
• Medical Device R&D
• Project Management
• Project Planning
• Change Control Board
• Configuration Management
• Cmii