Neel P.
Staff Engineer @Dexcom
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WORK HISTORY
Staff Engineer @Dexcom
Mesa, AZ, US
Enterprise System Implementation – Led the organization-wide digitization of the Receiving Inspection process, unlocking $1.5MM in direct cost savings over three years. Risk Management & Compliance – Spearheaded Sensor Risk Management as part of Design Verification & Validation, developing SOPs for CFR & ISO compliance to ensure regulatory excellence. Strategic Project Leadership – Led the creation of Project Definition Documents, Change Order Plans, and Design History File (DHF) management, driving structured and compliant product development. High-Volume Manufacturing Support – Played a key role in the manufacturing of 70MM+ Class II CGM devices, consistently maintaining a 95%+ rolled yield for sensor production. Quality & Supplier Management – Ensured compliance with 21 CFR Part 820 QSR & ISO 13485 by qualifying vendor-supplied parts, enterprise software, and internally manufactured components. Process Improvement & CAPA Execution – Led Corrective and Preventive Actions (CAPA), reducing manufacturing NCMRs by 10%, optimizing labeling, lot release, and sensor processes. Production Efficiency Gains – Drove a 15% YoY reduction in NCMRs for G6 & G7 production lines despite significant volume increases (G6 +21% & G7 +355%). Manufacturing Software & Equipment Validation – Led qualification of software & equipment following QMS protocols, covering FAT, SAT, IQ, OQ, and PQ. Regulatory & Audit Readiness – Successfully orchestrated Site Readiness for FDA, BSI-MDSAP, and AZBOP audits, achieving zero findings at a new manufacturing site. Scaling Production Capacity – Provided strategic quality leadership, supporting a 70% increase in sensor production capacity from 2020 to 2023.
EDUCATION
Symbiosis Institute of Business Management, Pune
Associate's degree, Business Administration and Management, General
Delhi Public School - Bopal, Ahmedabad
High School Diploma
Arizona State University
Master of Science (M.S.), Mechanical Engineering
SYMBIOSIS INTERNATIONAL UNIVERSITY
Bachelor of Technology (B.Tech.), Mechanical Engineering
SKILLS
ABOUT NEEL P.
With over eight years of experience in the medical device industry, I am a staff quality assurance engineer at Dexcom, a global leader in continuous glucose monitoring systems. I am a certified engineer in training (EIT) and a skilled mechanical engineer, with expertise in 3D printing, geometric dimensioning and tolerancing (GD & T), and metrology. In my current role, I lead the implementation of enterprise systems and procedures for improving quality compliance and data integrity, ensuring adherence to 21 CFR Part 11 and ISO 13485 standards. I also lead the quality engineering for facilities and equipment qualification and validation, supporting the design, development, and production of Dexcom\'s innovative products.
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