Sandeep Yadav Chakka

Experience

Verification & Validation Engineer

Vitara Biomedical Inc, Philadelphia, PA • Aug 2025 – Present

Led equipment validation activities for manufacturing and laboratory systems to ensure compliance with user requirements, regulatory standards, and quality system expectations
Support FDA IDE clinical trial submission for a neonatal care medical device by managing system-level verification activities within an ALM environment
Maintain and verify requirements, risk, and verification artifacts, ensuring alignment with current hardware and software revisions throughout development
Planned and executed complete IQ/OQ/PQ validation packages in alignment with validation master plans and regulatory requirements
Executed verification and validation (V&V) activities to confirm manufacturing processes, equipment, and systems met defined user requirements, design inputs, and regulatory expectations
Developed and executed system- and component-level verification test methods, protocols, and reports to verify mechanical and electromechanical requirements in accordance with ISO 13485 and FDA design controls
Qualified and validated manufacturing equipment including processing systems, packaging lines, and automated production machinery
Reviewed executed validation packages for completeness, traceability, and compliance prior to final approval
Supported internal and external audits by providing comprehensive documentation and technical justifications for validation activities
Conducted periodic reviews to confirm systems remained in a validated state and met ongoing performance requirements
Conducted risk assessments (PFMEA) to identify critical process parameters (CPPs) and critical quality attributes (CQAs) for validation planning
Ensured all executed protocols and reports met cGMP expectations for completeness, accuracy, and data integrity
Developed comprehensive validation protocols outlining scope, methodology, risk assessment, acceptance criteria, and testing requirements

Senior Manufacturing Engineer

Argon Medical Devices, Wheeling, IL • Jan 2023 – Jul 2025

Created and maintained process books, mold parameter verification systems, and quality documentation in response to CAPA findings
Transitioned to 3D-printed fixtures, saving machine time and material costs
Created 3D-printed fixtures for catheter assemblies (Centesis, Dipping Basket)
Installed and validated custom-made index table molding machines, optimizing production efficiency
Conducted Cpk & Ppk capability studies to assess process stability and reduce variability
Developed and executed FAT, SAT, IQ, OQ, PQ, and DOE validation protocols, ensuring robust process control
Designed and implemented a process flow for Validation from Factory acceptance till the transition to production
Managed Material Change Requests (MCRs) and Design Change Requests (DCRs)
Developed automation programs in R and VBA, streamlining process capability analysis and data visualization
Provided staff training on GMP, QMS documentation, and standard operating procedures (SOPs), ensuring regulatory compliance
Led supplier qualification and mold validation initiatives, ensuring conformance to quality standards
Implemented Microsoft Visio for process mapping and Microsoft Automate for workflow automation, increasing operational efficiency
Led a critical sustaining engineering project for a new IZI customer product facing post-launch failures including fit issues, mismatch, and part breakage. Redesigned mold components, updated engineering drawings, and commissioned new mold cores to resolve issues, enabling successful product relaunch and complaint closure
Investigated and resolved label mix-up traced to warehouse issuance error; recommended labeling workflow improvements and spatial reorganization to prevent recurrence
Introduced Cognex Vision systems for defect detection such as burrs, flashes and mismatch for grinded and molded parts

Manufacturing Engineer

Phillips-Medisize, Hudson, WI • Dec 2020 – Dec 2022

Executed IQ/OQ/PQ validation for 4 production lines, including 2 new product introductions involving filling and MPAC packing machines
Conducted DOE to resolve flap-tearing defects on packing boxes, reducing scrap through design adjustment and vision system integration
Provided support on CAPA investigations and effectiveness assessments
Provided staff training on regulatory requirements, specializing in GMP/QSR
Monitored, maintained, and controlled the QMS for regulatory purposes under ISO 13485 standards
Supported initiatives in all product manufacturing aspects: Production floor support, Yield, Quality improvement, Process Improvement and Documentation
Developed and executed IQ, OQ, and PQs for manufacturing processes and supporting manufacturing equipment and instrumentation
Prepared standard work sheets and job instruction sheets with visual aids and operation description
Modified and created drawings, test procedures and bill of materials as part of manufacturing line support
Responsible for the creation, documentation, maintenance, and control of Quality System Plans and Risk Management Plans
Supported investigations of non-conformance and CAPAs for operations and supply chain
Collaborated with Operations and Suppliers to close out audit findings or corrective actions
Gathered and analyzed manufacturing metrics and worked closely with Quality organization to define and validate appropriate process changes
Supported and/or performed internal audits of the quality system and Design History Files (DHFs)
Supported design verification / validation activities including protocol and report writing
Collaborated on process characterization, experimentation, optimization and qualifications
Initiated and led the resolution of non-conformances / CAPAs
Analyzed test data using statistical tools, performed in-depth interpretation of results, and generated detailed technical reports

Education

Master of Science – Mechanical Engineering

University of Texas at Dallas

Specialization: Materials, Manufacturing, and Machine Design

During my graduate studies, I explored the intersection of material science and computational modeling. My work included simulation of material cracking under mechanical stress, powder deposition techniques for additive manufacturing, and dynamic analysis of complex systems—including a novel study on the optimal paths and color combinations for solving a Rubik's cube. These projects combined FEA, statistical analysis, and algorithm development to push the limits of material performance and design automation.

Bachelor of Technology – Mechanical Engineering

Amrita University, India

Focus: Robotics and Smart Materials

As an undergraduate, I concentrated on robotics and soft actuators, developing custom robots and experimenting with bellow-type actuator designs using molded elastomers. My projects spanned design, fabrication, and control system integration—translating theoretical mechanics into functional robotic systems. These experiences laid the foundation for my interest in manufacturing innovation and engineering design.

Skills

Technical Tools & Software

SolidWorks, VBA, R

Micro-Vu, CMM, MiniTab

Microsoft Visio, Microsoft Automate

Data & Statistical Analysis

Design of Experiments (DOE)

Capability Studies (Cpk, Ppk)

Gage R&R, Statistical Process Control (SPC)

Fault Tree Analysis (FTA)

Test Method Validation (TMV)

Validation & Quality Systems

IQ / OQ / PQ

VSM, FAT, SAT

PFMEA, Control Plans

CAPA, NCR, NCMR

SOPs, Risk Management

ISO 13485, ISO 14971, ISO 594, ISO 80369-7

21 CFR Part 820 (QMS Compliance)

Manufacturing & Engineering

Lean Manufacturing, Six Sigma (DMAIC)

Process Optimization, Root Cause Analysis

Non-conformance Handling

Supplier Audits & Qualification

Product Development & Mold Validation

Finite Element Analysis (FEA)

Certifications

Lean Six Sigma Black Belt

CSSC

Advanced expertise in process improvement methodologies and statistical analysis for manufacturing optimization.

Certified SolidWorks Professional

CSWP

Professional-level proficiency in 3D CAD design and engineering documentation.

CSWA – Additive Manufacturing

CSWA-AM

Specialized knowledge in 3D printing technologies and additive manufacturing processes.

CSWA – Electrical Design

CSWA-E

Competency in electrical system design and integration within mechanical assemblies.

Certified SolidWorks Associate

CSWA

Fundamental proficiency in SolidWorks CAD software and mechanical design principles.

Contact

Get In Touch

(872) 240-0693

csytpty@gmail.com

Wheeling, IL

Hello! I'm Sandeep