Sandeep Yadav Chakka

Sr Validation Engineer

Vitara Biomedical Inc, Philadelphia, PA

Aug 2025 – Present

Leading verification and validation activities in preparation for FDA IDE submission for a neonatal care medical device — managing system-level verification within an ALM environment, maintaining bidirectional traceability between system requirements, identified risks, and verification evidence
Planned and executed complete IQ/OQ/PQ validation packages aligned with validation master plans, regulatory requirements, and cGMP standards for completeness, accuracy, and data integrity across manufacturing and laboratory systems
Developed and executed system and component-level verification test methods and protocols for mechanical and electromechanical requirements per ISO 13485, FDA design controls, and ISO 14971 risk management framework
Conducted PFMEA-based risk assessments to identify CPPs and CQAs; developed risk-based test runs defining verification intent and coordinated execution across cross-functional R&D teams — investigating defects and implementing corrective fixes to meet clinical and regulatory requirements
Supported CAPA investigations including a critical case on cannulator blood leakage — analyzed test data, identified probable causes, and recommended design and process modifications
Performed blood flow data analysis to validate device performance against design inputs and clinical requirements; authored test protocols, reports, and risk documentation including FMEA and fault tree analysis for submission deliverables
Designed and modified custom test fixtures for repeatable validation testing; developed a calibration equipment inventory management application tracking due dates and compliance status to improve audit readiness
Reviewed and approved design and verification artifacts for consistency with system configuration and regulatory expectations; led QMS improvement initiatives reducing documentation gaps across multiple design teams

Sr Manufacturing Engineer

Argon Medical Devices, Wheeling, IL

Jan 2023 – Jul 2025

Led full lifecycle IQ/OQ/PQ validation of injection molding systems and auxiliary equipment — dryers, chillers, and material loaders — for Class II and III medical devices; executed Computer System Validation for quality-critical ERP platforms in compliance with FDA 21 CFR Part 820 and ISO 13485
Converted legacy rotary-table injection platforms from plunger-based to screw-based injection technology — integrating Arburg injection units with proprietary rotary-table systems, defining system-level integration of mechanical subsystems, automation, sensors, and HMI interfaces, and developing all process documentation from scratch
Implemented FAT and SAT methodologies to identify tooling and system integration risks prior to formal validation; served as escalation point for complex failures involving tooling, automation, and control interfaces, driving permanent corrective actions
Led full-scale CAPA investigation into Supercore VLT II biopsy device failures — developed a Fault Tree Analysis identifying 4 root causes across tooling, assembly, and incoming components; resulted in a redesigned validated mold, SCAR issuance to needle supplier, and 100% effectiveness verification
Built R and VBA automation tools for DOE execution, Cp/Cpk capability analysis, ANOVA-based cavity effect detection, and OQ/PQ pass/fail reporting — standardizing a previously manual statistical process across the engineering team
Reduced incoming inspection cycle time from 400 minutes to 1.5 minutes through Micro-Vu automation scripting — eliminating manual data recording and enabling direct data feed into capability analysis workflows
Built and maintained a PDM-controlled database of 3,006 parts across 178 resins with MCR/DCR workflows and CAPA-driven process books — replacing retrospective validation with defined process windows across 3,000+ SKUs and 60+ materials
Designed and deployed Keyence vision inspection systems for in-process dimensional and defect detection; integrated Arburg safety interlocks and light curtains; implemented Microsoft Visio for process mapping and Microsoft Automate for workflow automation
Led Gage R&R and TMV studies; conducted Cpk/Ppk capability studies; owned PFMEA and machine PFMEA documentation; participated in EU MDR remediation aligning legacy validation evidence with updated risk management files
Designed 3D-printed fixtures for catheter assemblies (Centesis, Dipping Basket) reducing tooling cost and lead time; resolved post-launch part failures by redesigning mold components in SolidWorks and commissioning new mold cores via PDM-controlled ECO workflows
Trained staff on GMP, QMS, SOPs, and regulatory compliance; supported NPD/NPI projects integrating validation requirements early in development; collaborated with R&D, QA, Manufacturing, and Regulatory to align validation objectives

Manufacturing Engineer

Phillips-Medisize, Hudson, WI

Dec 2020 – Dec 2022

Executed IQ/OQ/PQ validation across 4 production lines — including 2 new product introductions involving filling automation and MPAC packing lines — in a Class II/III medical device environment compliant with ISO 13485 and FDA 21 CFR Part 820
Contributed to design transfer and NPI of a regulated electromechanical manufacturing platform — translated product design intent into manufacturing and process requirements, led setup and qualification of new lines as the interface between product design, manufacturing systems, and validation
Applied Six Sigma DMAIC framework to develop injection molding process parameters; conducted DOE-driven analysis to resolve flap-tearing defects on packing boxes through targeted design adjustments and Cognex vision system integration
Led CAPA investigations and NCR resolutions across operations and supply chain — performed root cause analysis, developed corrective action plans, verified effectiveness, and drove process changes to reduce recurring non-conformances
Conducted Measurement System Analysis including Gage R&R studies, process capability studies, and sampling plan development; performed statistical analysis to identify trends and reduce variability across multiple product lines
Maintained QMS documentation under ISO 13485 — authored validation protocols, reports, SOPs, risk management plans, and work instructions with visual aids; supported DHF and DMR maintenance and internal audits
Participated in supplier audits to evaluate validation compliance; served as quality liaison during FDA inspections; supported regulatory submissions with complete, traceable risk documentation
Collaborated with Quality, R&D, and Operations to transfer validated injection molding processes from pilot to commercial manufacturing; developed FAT protocols and performed process optimization for new molding equipment

Hello, I'm Sandeep

Experience

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Education

Master of Science, Mechanical Engineering

Bachelor of Technology, Mechanical Engineering

Certifications

Lean Six Sigma Black Belt

Certified SolidWorks Professional — Design

Certified SolidWorks Associate — Design

CSWA – Additive Manufacturing

CSWA – Electrical Design

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Sandeep Yadav Chakka

Hello, I'm Sandeep

Experience

Featured Projects

Education

Master of Science, Mechanical Engineering

Bachelor of Technology, Mechanical Engineering

Certifications

Lean Six Sigma Black Belt

Certified SolidWorks Professional — Design

Certified SolidWorks Associate — Design

CSWA – Additive Manufacturing

CSWA – Electrical Design

Contact

Get In Touch

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