Sandeep Yadav Chakka

Hello, I'm Sandeep

I'm a manufacturing engineer with more than 5 years of experience in medical device manufacturing. I specialize in molding, filling, and packing processes, working with both mechanical and electro-mechanical device classes. Throughout my career, I've developed a deep passion for finding cost-effective solutions and solving complex manufacturing challenges. My commitment to upholding the highest quality standards drives everything I do—ensuring that the products we develop not only meet but exceed regulatory requirements and customer expectations. I believe that excellence in manufacturing is the foundation of patient safety and product success.

Experience

Sr Validation Engineer

Vitara Biomedical Inc, Philadelphia, PA

Aug 2025 – Present

Equipment Validation: Design and execute comprehensive IQ/OQ/PQ protocols for manufacturing and laboratory systems ensuring FDA compliance and regulatory standards
FDA IDE Support: Manage system-level verification activities and requirements traceability for clinical trial submissions within ALM environment
Risk Management: Conduct PFMEA assessments to identify critical process parameters and quality attributes for validation planning
Testing & Protocols: Develop and execute system and component-level verification test methods aligned with ISO 13485 design control requirements
Audit Readiness: Review and maintain validation packages for completeness, traceability, and compliance prior to regulatory submissions

Sr Manufacturing Engineer

Argon Medical Devices, Wheeling, IL

Jan 2023 – Jul 2025

Validation Leadership: Led complete lifecycle equipment validation projects for new injection molding systems and auxiliary equipment with planning, execution, and comprehensive reporting
Vision System Implementation: Designed and deployed Keyence vision inspection systems for in-process dimensional and defect detection, improving quality metrics and reducing manual inspection
Process Validation: Developed and executed IQ/OQ/PQ protocols for injection molding equipment used in Class II and III medical device manufacturing
Statistical Analysis: Conducted Cpk, Ppk capability studies and DOE validation protocols to establish robust process parameters and control limits
Supplier Management: Led supplier qualification and mold validation initiatives ensuring conformance with internal quality standards and regulatory requirements

Manufacturing Engineer

Phillips-Medisize, Hudson, WI

Dec 2020 – Dec 2022

Production Line Validation: Executed IQ/OQ/PQ validation for 4 production lines including 2 new product introductions with filling and packaging equipment
Process Optimization: Conducted DOE studies to resolve defects and reduce scrap rates through design adjustments and vision system integration
Quality Systems: Monitored, maintained, and controlled QMS under ISO 13485 standards with comprehensive documentation and audit support
Design Support: Supported design verification/validation activities, internal audits, and DHF maintenance across multiple product lines
CAPA Management: Investigated non-conformances, led CAPA effectiveness assessments, and implemented corrective actions across operations and supply chain

Education

Master of Science, Mechanical Engineering

University of Texas at Dallas

Specialization: Materials, Manufacturing, and Machine Design. Research focused on material science, computational modeling, FEA, and dynamic systems analysis.

Bachelor of Technology, Mechanical Engineering

Amrita University, India

Focus: Robotics and Smart Materials. Projects in design, fabrication, control systems integration, and soft actuator development.

Skills

Validation & Quality Systems

IQ/OQ/PQ, FAT/SAT, PFMEA, CAPA, NCR/NCMR, SOPs, ISO 13485, ISO 14971, 21 CFR Part 820, Risk Management

Data & Statistical Analysis

DOE, Gage R&R, Cpk/Ppk, SPC, FTA, TMV, Control Plans, MiniTab, Statistical Modeling

Tools & Software

SolidWorks, VBA, R, MiniTab, Micro-Vu, CMM, Microsoft Visio, Microsoft Automate, SQL

Manufacturing & Engineering

Lean Manufacturing, Six Sigma (DMAIC), Root Cause Analysis, FEA, Supplier Audits, Product Development, Vision Systems

Hello, I'm Sandeep

Experience

Featured Projects

Education

Master of Science, Mechanical Engineering

Bachelor of Technology, Mechanical Engineering

Skills

Validation & Quality Systems

Data & Statistical Analysis

Tools & Software

Manufacturing & Engineering

Certifications

Lean Six Sigma Black Belt

Certified SolidWorks Professional

CSWA – Additive Manufacturing

Certified SolidWorks Associate

CSWA – Electrical Design

Contact

Get In Touch

Sandeep Yadav Chakka

Hello, I'm Sandeep

Experience

Featured Projects

Education

Master of Science, Mechanical Engineering

Bachelor of Technology, Mechanical Engineering

Skills

Validation & Quality Systems

Data & Statistical Analysis

Tools & Software

Manufacturing & Engineering

Certifications

Lean Six Sigma Black Belt

Certified SolidWorks Professional

CSWA – Additive Manufacturing

Certified SolidWorks Associate

CSWA – Electrical Design

Contact

Get In Touch

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