Akash Nalluri
North Haven
Summary
Manufacturing Engineer with a Master’s degree in Industrial Engineering and hands-on experience in medical device manufacturing. Skilled in implementing Lean principles, managing MDR and FDA compliance project, and executing change development plans across complex production lines. Proficient in creating and reviewing validation protocols (IQ, OQ, PQ), troubleshooting packaging and labeling systems, and leading sterilization optimization projects. Strong background in statistical analysis using Minitab and data-driven process improvements. Experienced with optimizing production workflows and streamlining operations. Track record of successfully leading cross-functional teams to drive continuous improvement initiatives. Committed to ensuring regulatory compliance, operational efficiency, and high-quality manufacturing standards.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Manufacturing Engineer
Medtronic
09.2023 - Current
- Created and managed Change Development Plan (CDP) in Agile for multiple manufacturing lines, aligning deliverables with MDR requirements and project timelines.
- Provide day-to-day support on the production floor by troubleshooting packaging and labeling issues to minimize downtime and ensure smooth operations. Collaborate with operators, quality, and engineering teams to resolve real-time problems related to label printers, vision systems, and packaging equipment.
- Drafted and reviewed key validation documents including IQ, OQ, PQ, TMV, and Master Validation Plans for new and updated manufacturing lines.
- Created BOM for versioned Finished Goods (FGs) to support MDR compliance, ensuring accurate traceability and seamless integration into SAP and Agile PLM.
- Reviewed and approved PPAPs in coordination with supplier quality teams to validate parts and ensure compliance with quality standards.
- Designed and optimized manufacturing layouts and processes with a focus on ergonomic design and efficiency.
- Performed Operational Qualification (OQ) of Alloyed Sealers PQ data (t-tests, ANOVA) using statistical software, Minitab.
- Proficient in using Agile, Maxima, MES, Prisym, Software LLM, Polarion, Software spectrum, Selerumation and BPCS.
- Implemented Print-on-Demand (POD) software across the site for packaging component verification, integrating with PLC logic to validate presence of IFUs, patient labels, PIC cards, and box labels in the final box during line operations.
- Experienced in configuring and troubleshooting CK67 handheld scanners for production floor operations, including lot tracking, label verification, and real-time data entry.
- Familiar with intelligent printers (e.g., PX4i, PX6i) for automated label printing, integrating with MES and PLC systems to support accurate and compliant packaging processes.
- Implemented Lean manufacturing principles across product assembly lines, leading to measurable waste reduction and improved operational efficiency.
- Worked on creating standard operating procedures, process maps, work instructions and engineering Datasheet for manufacturing and supply chain equipment based on mapping studies.
- Involved in sterilization optimization projects, collaborating with cross-functional teams to design new sterilization cycles with reduced ethylene oxide (EO) usage and shorter cycle times, improving efficiency and regulatory compliance.
- Investigated non-conformances and implemented effective Corrective and Preventive Actions (CAPA) to address root causes and maintain product quality.
- Led installation and validation of new production equipment, collaborating with vendors.
- Provided technical assessments on Change Controls, Deviations, and Technical Investigations.
- Handled investigations in Trackwise for Product Deficiencies and Process Deviations during manufacturing of Exhibit batches and Process-Validation Batches.
Manufacturing Intern
Natco Pharma
06.2021 - 11.2021
- Involved in the preparation of validation protocols for QC Micro laboratory, manufacturing equipment in compliance with cGMP guidelines, MDR regulations and industry standards.
- Assisted in developing and executing documents such as Change Control, Validation Plans, Standard Operating Procedure (SOP), Design Qualification (DQ), Test protocols (IQ, PQ, OQ), technical summary/ final reports, Deviation investigations, Deviation notifications.
- Assisted in executing IQ protocol for TOC Analyzer, HPLC, Tablet Compression Machines, Tanks, Plate washers, PH Meter, Conductivity Meter, Blenders, Mixers and Microscopes
- Used Minitab software for evaluating the quality attributes in process validation.
- Assisted in identifying critical process parameters (CPPs) and Critical Quality attributes (CQAs) for liquid products.
- Updated equipment information, calibration schedule, provide maintenance schedule, requalification due dates and schedules.
- Trained in QMP Quality Systems such as change control, change management, Quality Management System (QMS), Risk Management, Deviations.
Intern
ISUZU Motors India Private Limited
05.2019 - 05.2019
- Reduction of NVA (Non-Value added) Process in TFC (TRIM FINAL CHASIS LINES).
- Identified Appropriate Methodology to Shorten Cycle time and Achieved target margins.
- Implementation of Kaizen activities in assembly line to eliminate the Non-Value added activities Present.
- Value stream mapping and 8 Wastes are the lean methods used to find out the NVA.
Campus Manger
Garage Preneurs Pvt. Ltd
02.2018 - 04.2019
- Operations and Marketing of the Organization.
- Increased company growth through collaboration with sales and marketing departments.
- Working Knowledge and Experience with Financial Reporting and Auditing.
- Acting as a College Financial Approver, Coordinating and Overseeing the Activities of students, arranging and Organizing events.
- Improved communication abilities due to frequent interactions with others.
Education
Master of Science - Industrial Engineering
University of Houston
Houston, TX05.2023
Bachelor of technology - Mechanical Engineering
CHRIST (Deemed to be University)
06.2021
Skills
- Manufacturing processes
- Process improvement
- 5S methodology
- Process development
- Quality control
- Manufacturing automation
- Risk assessment
- Manufacturing resource planning MRP
- Minitab
- Workstation design
- Computer-aided manufacturing
- Assembly line optimization
- PTC CREO parametric
- Cost reduction programs
- Corrective action activities
- Root-cause analysis
- Lean manufacturing
- Bill of material (BOM)
- Continuous improvement
- Equipment installation
- Continuous improvement methods
- Packaging design
Certification
- Certified Lean Six Sigma Yellow Belt - Medtronic
- Certified Lean Six Sigma Green Belt. - Udemy
- Certification in Industrial Automation FESTO from Christ (Deemed to be University), Bangalore, India
Timeline
Manufacturing Engineer
Medtronic
09.2023 - Current
Manufacturing Intern
Natco Pharma
06.2021 - 11.2021
Intern
ISUZU Motors India Private Limited
05.2019 - 05.2019
Campus Manger
Garage Preneurs Pvt. Ltd
02.2018 - 04.2019
Bachelor of technology - Mechanical Engineering
CHRIST (Deemed to be University)
Master of Science - Industrial Engineering
University of Houston
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