Aseem Kandel Email & Phone Number

Alpharetta, Georgia, United States

Westford, Massachusetts, United States

• Provided guidance to the Sustaining Product Development and R&D teams in aspects of the QMS related to Design Controls and Risk Management for real time co-registration side-by-side viewing of OCT intravascular imaging and angiography (Simultaneous angio and OCT image acquisition).• Using engineering principles, analyzed situations or data to identify gaps between project work and QMS elements.• Developed mastery of Class II and III products and analyzed complaint data, post market… Show more • Provided guidance to the Sustaining Product Development and R&D teams in aspects of the QMS related to Design Controls and Risk Management for real time co-registration side-by-side viewing of OCT intravascular imaging and angiography (Simultaneous angio and OCT image acquisition).• Using engineering principles, analyzed situations or data to identify gaps between project work and QMS elements.• Developed mastery of Class II and III products and analyzed complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on EU MDR principles and data analysis via risk-based approach.• Lead Risk Management File remediation and/or creation activities by delivering Hazard Analysis, D/U/P FMEAs, RMP/RMR, and cybersecurity risk analysis for measurement systems for the guidewires, wireless communication devices, and catheters.• Worked within the QMS to support the Design Assurance process to assure the Design History File (DHF) content integrity with the assessment and implementation of design changes to existing medical devices to comply with the FDA regulations, operating procedures, task assignments and other regulatory bodies.• Identified primary root causes and implemented corrective actions and preventive actions (CAPA) with plan design, investigation, development of actions and effectiveness verification of CAPA implementation for quality issues.• Lead to the process improvement by identifying methods to capture the quality metric data.• Identified and controlled manufacturing process defects (scrap, nonconforming material, and customer complaints). • Supported internal (Abbott Vascular, Abbott Quality and Regulatory) and external audit responses (BSI, EU MDR). • Proven track record with various statistical software and tools for conducting statistical analysis. • SME for supporting submission of China PRER (Periodic Risk Evaluation Report) for China NMPA.• IFU updates • Quality plans Show less

Arlington, Texas, United States

Used active learning techniques in class to coach students for algorithm development and engineering concepts with engaging 5000+ students to solve engineering problems over the period of 4 years.

Master Of Science - Ms, Biomedical/Medical Engineering, 4.0

Bachelor Of Science - Bs, Biomedical/Medical Engineering, 3.41