Neel P.

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.

Experience

1. Staff Engineer

   Dexcom

   Mar 2022 — Present · 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

  2010 — 2013

• Delhi Public School - Bopal, Ahmedabad

  High School Diploma

  2002 — 2009

• Arizona State University

  Master of Science (M.S.), Mechanical Engineering

  2013 — 2015

• SYMBIOSIS INTERNATIONAL UNIVERSITY

  Bachelor of Technology (B.Tech.), Mechanical Engineering

  2009 — 2013

Skills

• Ptc Creo
• Fluent
• Ansys
• Product Development
• Hvac
• Calypso
• Finite Element Analysis
• Thermodynamics
• Design of Experiments
• Manufacturing
• Heat Transfer
• Microsoft Excel
• Powerpoint
• Welding
• Geometric Dimensioning & Tolerancing
• C++
• Mechanical Engineering
• Autocad
• Teamwork
• Fda Gmp
• Windows
• Failure Mode and Effects Analysis (Fmea)
• Lean Manufacturing
• Cae
• C
• Programming
• Solidworks
• Microsoft Office
• Catia
• Project Engineering
• Fmea
• Matlab
• Medical Devices
• Engineering Design
• Pro Engineer
• Injection Molding
• Moldflow
• Root Cause Analysis
• Computer-Aided Design (Cad)
• Engineering