Ravichandra Mikkilineni

About Ravichandra Mikkilineni

I am a highly accomplished and results-driven Senior Quality and Manufacturing Engineer with extensive experience in driving innovation, improving processes, and delivering measurable impact in regulated industries. With a robust background in manufacturing engineering, process validation, and project management, I specialize in transforming complex challenges into streamlined, high-performing solutions.My technical expertise spans a wide range of advanced methodologies, including Six Sigma, Lean Manufacturing, and Total Quality Management, which I leverage to optimize production efficiency, reduce costs, and enhance product reliability. Proficient in cutting-edge tools and techniques such as FMEA, DOE, SPC, MSA, and test method validation, I consistently ensure compliance with international standards such as ISO 13485, ISO 14971, and FDA 21 CFR Part 820.Over the course of my career, I have spearheaded high-stakes projects such as the duplication of manufacturing lines, design change initiatives, and process optimization for leading organizations like Dexcom Inc. and Medtronic Neurovascular. Notable achievements include:Reducing curing cycle times by 58%, saving $1.8M annually through streamlined processes and efficient team management.Developing and qualifying innovative manufacturing protocols for new product launches, ensuring regulatory and quality compliance.Managing cross-functional teams, collaborating with suppliers, and leading equipment buyoff, FAT/SAT, and V&V activities for automation systems.I thrive in fast-paced, high-pressure environments, where my ability to analyze data, perform root cause investigations, and lead CAPA initiatives ensures successful outcomes. With advanced certifications in Six Sigma Green Belt, Lean Processes, and Executive Management, I am equipped to lead multidisciplinary teams, deliver transformative results, and drive continuous improvement.As a technical leader with strong interpersonal skills, I bridge engineering excellence with strategic vision, ensuring quality, compliance, and efficiency in every project I undertake.

Experience

1. Staff Quality Engineer- Manufacturing Automation

   Dexcom

   Mar 2025 — Present

   Design, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for distribution.Takes the initiative to develop systems and processes that improve product safety; increase product consistency and conformance to requirements; reduce costs.Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.Performs analysis of reports and production data to identify trends and recommend updates or changes to quality SOP.Reviewing, authoring documentation including design history file, standard operating procedures, Protocol nd reportsDesigns and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibration, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls.Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.Participating and assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.Designs and performs Equipment, Process, Software and Test Method Validations.Provides technical guidance with respect to equipment, software, product, and process requirements including defining and identifying failure mode effects and analysis (FMEA) Applies risk management, validation, sample size, and external standards review and implementation activities. Assists with investigation and disposition of nonconforming materials with the Materials Review Board.

Education

• Bradley University

  Master of Science - MS, Mechanical Engineering

Skills

• Research
• Minitab
• Microsoft Office
• Management
• Public Speaking
• Autocad
• Lingo
• Logware
• Project Management
• Catia
• Customer Service
• Leadership
• Ibm Cplex
• Powerpoint
• Microsoft Excel