Stefan Stefanov's Linkedin Analytics

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 STANDARDS 21 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 60601-1 3rd Ed. IEC 60601-2-52, IEC 60601-1-4, IEC 60601-1-6, ISO 62366-1:2015, ANSI/AAMI HE75, UL2601-1 MIL & DO STANDARDS MIL-STD-499, MIL-STD-1472, MIL-STD-6011, MIL-STD-6016,MIL-STD-704, MIL-STD-461, DO-160