Samir Sharma Email & Phone Number

Experienced Technical Leader with a demonstrated history of managing global product safety, regulatory compliance, and reliability/validation/warranty for innovative organizations of various sizes (from start-ups to more than $40B), in different industries. Strong product development, program, and project management professional who graduated from Stanford GSB and Arizona State University. Expert in: Regulatory Compliance Framework/management, Design for Technical Compliance, Design for Safety, CE marking; Environment, Health, and Safety (EHS) management, ISO 45001, OSHA/FDA/NFPA/NRTL/CFR compliance; Compliance Engineering, Consumer Electronics, Electrical, Industrial, Machinery, Power Electronics, Electro-Mechanical, Complex systems, Transporation, Medical/Healthcare, FDA/Quality System Requirements (QSR), cGMPs, and design control, 510(K), Oil & Gas, Robotics and Automation, EMC, litigation matters and deposition, Product Safety, human factor analysis, Electric vehicles, charging stations, Automotive and autonomous vehicles. Functional Safety (IEC 61508, ISO 26262, IEC13849, IEC62061), Risk Assessment and Management (ISO 12100, ISO 14971), and techniques - HAZOP/DFMEA/FTA/HARA/SISTEMA/SOTIF. Hazardous Area (IECEx/ATEX), Product Stewardship, Environmental Compliance (REACH, RoHS, WEEE, CA Prop 65, Conflict of Minerals, EPA, EnergyStar), Energy/Renewable Energy (Solar, Wind, Batteries, Energy Storage, Hybrid, Fuel cells, Aeroderivatives, Gas/Steam Turbines), Vessels (ASME/PV/PED), Lifts, Agriculture, Irrigation, IoT (radio communication - RF, wireless, GPS, GSM, CDMA, spread spectrum, RED, FCC), building and fire safety, OSHA. Consumer Product Safety Commission (CPSC). Safety incident tracking, reporting, and mitigation. Product Recall Management. Reliability Engineering (DfR and FRACAS) and Quality/Supplier Quality. ISO 9001, ISO 13485. Lean Six Sigma. Testing, Test lab development, accreditations, ISO 17025, UL DAP, and Intertek Satellite lab program. Global approvals/certifications/homologation (IEC, UL, EN/CEN, ASTM, TUV, DNV, CSA, NOM, Intertek, ANATEL, and other safety and telecom approvals). Global Market Access (GMA) with personal contacts in most countries/regions. Quality and regulatory audits. International export compliance. Global Standard Development (a member of several UL STPs, IEC TCs, NFPA CMP, etc.) - official US delegate to several global standard bodies. Prepare organizations for the ever-changing product regulatory landscape and adapt.

Listed skills include Photovoltaics, Solar Energy, Engineering, Engineering Management, and 45 others.