Kaveh Momen

Background

About Kaveh Momen

An experienced "Choice Theory*" leader with 11+ years in team building and 20+ years in hands-on medical device design. Proven ability to bring medical devices from concept to production, meeting IEC standards and regional regulatory requirements (Health Canada, USA FDA, European MDR, and Australian TGA). Excels in strategic execution, regulatory compliance, and team leadership. Highlights:* Medical Device Product Development and Operation management per ISO 13485:2016, MDSAP (Health Canada, FDA, Australian TGA), and European MDD/MDR.* Team Leader - A captain of the ship who doesn’t blame the storm and he will navigate the ship to safety - Team management & mentoring (engineers, software developers, technicians, clinicians, etc.)* Project management * Medical Device Product Development - Medical device safety (IEC 60601-1)- Medical device Electromagnetic Compatibility EMC (IEC 60601-1-2)- Medical device software lifecycle (IEC 62304)- Usability engineering in medical devices - IEC 60601-1-6 & IEC 62366 - Application of risk management to medical devices - ISO 14971:2019 - Medical device in home healthcare environment - IEC 60601-1-11 - Medical Lasers (IEC 60601-2-22 & IEC 60825)* Research & Development * Biomedical and Rehabilitation Engineering. Highlights on the Technical Skills:* Biomedical Signal Processing (EEG, EMG, ECG, MMG, etc.)* Sensors and Biosensors (EEG, EMG, ECG, MMG, Accelerometers, etc.)* Digital and Analog designs including PCB design * Embedded and Wearable Systems * Programming (firmware, software)* Artificial Intelligence (AI) and Machine learning * Digital Signal Processing (DSP), and Adaptive Digital Signal Processing *NOTE: For more information about "Choice Theory" Please refer to the book by Dr. William Glasser. You may also want to read about "Herb Kelleher", the co-founder, later CEO of Southwest Airlines. He was practicing "Choice Theory" in how he ran his company.