Stefan Stefanov

About Stefan Stefanov

Highly accomplished and results driven professional with demonstrated ability to lead and manage product developmental activities throughout the product life cycle process. Skilled in developing and executing strategic and tactical franchise initiatives, develops and drives “Voice of Customer” requirements at product conception through development and launch, Acts as the primary liaison between the product development and field. Known for delivering high-quality work on time, under budget and within tight timelines. Superb communication, interpersonal, leadership and project management skills; excels in challenging environments. Language proficiency in English, Bulgarian and Russian Languages Specialties: Areas of Key Strengths:• Engineering Project Management• Systems Engineering• System Design & Testing• Usability Design Validation• Product Development/Integration• Process Implementation and Validation• Statistical Quality Control Analysis • Product Management • Product Mapping and Messaging• Revenue and Profit Growth MED DEVICE STANDARDS21 CFR PART 801(LABELING), 21 CFR 803 (MEDICAL DEVICE REPORTING), 21 CFR PART 820 (GMP) QUALITY SYSTEMS REGULATIONS (QSR), ISO-9001:2015, ISO-13485:2016, ISO 14971:2007, IEC 60•••13rd Ed. IEC 60••••52, IEC 60•••14, IEC 60•••16, ISO 62366-1:2015, ANSI/AAMI HE75, UL2601-1 MIL & DO STANDARDSMIL-STD-499, MIL-STD-1472, MIL-STD-6011, MIL-STD-6016,MIL-STD-704, MIL-STD-461, DO-160

Experience

1. Director, Research and Development

   AtriCure, Inc.

   Mar 2022 — Present · Mason, OH, US

Education

• Adlai Stevenson H.S

  High School Diploma

  1992 — 1995

• University of Central Oklahoma

  B.S, Biomedical Engineering

  2002 — 2005

• The University of Alabama in Huntsville

  M.S, Industrial and Systems Engineering

  2009 — 2013

• Xavier University

  Master of Business Administration (M.B.A.), Pricing

  2013 — 2016

Skills

• Statistical Quality Control
• Design Control
• Program Management
• Systems Engineering
• Quality System
• Engineering Management
• Electronics
• Six Sigma
• Minitab
• Root Cause Analysis
• Engineering
• Aerospace
• U.s. Food and Drug Administration (Fda)
• Product Development
• R&D
• Security Clearance
• Validation
• Design of Experiments
• Manufacturing
• Fda
• Process Improvement
• Medical Device Regulatory Compliance
• Human Factors
• Research and Development (R&D)
• Fmea
• Medical Devices
• Capa
• Iso 13485
• Testing
• Electrical Engineering
• Quality Control
• Cross-Functional Team Leadership
• Compliance