Swalaxmi Pandit
Senior System Software Quality Engineer @Beckman Coulter Diagnostics
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WORK HISTORY
Senior System Software Quality Engineer @Beckman Coulter Diagnostics
Systems and Software Quality engineer driving AI based clinical diagnostic solutions (SaMD).Experience in software QMS processes, software development life cycle, risk management processes and design controls activities for SaMD medical devices.
EDUCATION
University of Mumbai
Bachelor of Engineering - BE, Information Technology
Wichita State University
Master of Science - MS, Electrical and Computer Engineering
ABOUT SWALAXMI PANDIT
Experienced systems engineer with strong software and systems engineering background in highly regulated industries in medical devices (SaMD, AI/ML, cloud based products, Clinical Decision Support devices, Class II, Class devices). Experience as a Systems Engineer in New Product Development projects/core teams leading extended team members for projects that include platform, applications, software, and machine learning algorithms.Specialties: New product development, design controls, risk management lead experience (system/ design/ process/ use risks, hazards & harms), cybersecurity (privacy and security requirements, risk assessment) Software Development Life Cycle (SDLC), verification & validation, design traceability, Design History File (DHF), quality assurance.Practical knowledge and experience of regulatory submissions for EU MDR and FDA 21 CFR Part 820, IEC 60601-1, ISO 13485 design controls, SDLC IEC 62304, risk management ISO 14971.
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