YASH CHAUDHARI
San Diego,CA
Summary
Packaging professional with 7+ years of experience in project management, packaging development, V&V, and continuous improvement projects in a regulated industry . Committed to providing result-oriented leadership that translates organization vision and goals into successful product and programs with interdepartmental collaboration and strategic planning.
Overview
9
9
years of professional experience
Work History
Engineering Manager
Alphatec Spine, Inc
10.2021 - Current
- Led and managed packaging and labelling team to formulate packaging, sterilization, and labelling strategies for NPI and sustaining Alphatec products
- Drove ASTM packaging standards test method harmonization to simulate Alphatec biologics distribution system including cold chain
- Supported Regulatory team to draft packaging, sterilization, labelling and endotoxin monitoring sections of 510k submissions
- Oversaw implementation and integration to new ERP system from dynamic labelling and routine sterile product monitoring standpoint
- Worked with cross -functional teams to qualify turnkey operations with CMOs which resulted in $2.3M+ cost savings and 33% reduction in lead times
- Initiated and managed continuous improvement projects for labelling for creation and label review
- Collaborated with supplier quality and supply chain teams to perform onsite supplier audits, qualification and ultimately supplier selection as a packaging and sterilization SME
- Created business case for transitioning non-sterile product into terminally sterilized product to achieve operational efficiency and reduction in pr-operative set up time.
Senior Packaging Engineer
Alphatec Spine, Inc
10.2018 - 10.2021
- Developed and managed packaging and sterilization projects to meet organization needs to launch product domestically and internationally
- Created Sterility Assurance program for routine monitoring for radiation and Ethylene oxide sterilization per ISO standards
- Developed and maintained technical project timelines and provide updates and feedback to project leadership
- Implemented changes to commercial packaging system as necessary to support corporate objectives
- This typically included identifying requirements, collaborating with multi-department leadership, communicating with vendors, updating technical documentation
- Performed supplier quality assessment through vendor relations with supplier audits and regular communication
- Provided subject matter expertise and rapid problem resolution to packaging and sterilization related NCMR’s, CAPAs, complaints and audits.
Senior Development Engineer
NuVasive, Inc
San Diego, CA
02.2016 - 09.2018
- Managed sterile packaging development projects to meet company needs in compliance with medical device regulations to launch sterile product domestically and internationally
- Managed and communicated cross functional team resources and responsibilities within packaging project scope
- Collaborated with marketing team to enhance packaging design to improve user experience, marketability, and recognition in medical device industry
- Created sterile pack development roadmap and train the team for consistent development process
- Worked on design control and design history documentation for sterile packaging projects
- Translated requirements of ISO-11607-1 for terminally sterilized products to product development teams
- Design and developed packaging for Nuvasive sterile products requiring ETO or radiation sterilization for domestic and international markets
- Formulated sterile packaging, sterilization, and labelling strategy for sterile 510K submissions and perform validations
- Created and executed sterilization and packaging process validations
- Developed labelling, barcodes, and symbology as per UDI requirements
- Created packaging related SOP’s, work instructions according to appropriate ISO standards
- Performed packaging test equipment qualification as per ISO-11607 – 2.
Application Specialist
TechNova Imaging Systems Pvt. Ltd
Mumbai
08.2010 - 07.2013
- Rendered support for product application and troubleshooting, using
- Six-Sigma – implementing DMAIC in development of existing and new product lines
- Kaizen - implementing Fishbone, 4W1H, Root Cause Analysis (RCA) and PDCA
- Successfully achieved 5S for continuous improvement and production efficiency on printing press floor
- Maintained and timely updated the technical database of around eight hundred printing and packaging clients
- Managed order log and supply chain activities for printing and packaging vendors and direct clients
- Creating customer satisfaction reports based on Cause and Effect (C-E) analysis.
Education
Master of Science - Packaging Science
Rochester Institute of Technology
Bachelor of Engineering - Printing Engineering
University of Pune
Skills
TECHNICAL SKILLSSoftwareSAP, AGILE Product Life Cycle Management software, TOPS, CAPEStatistical Tools (Minitab,), Life Cycle Assessment (COMPASS)Microsoft Office SuiteProcess Improvement and Quality ControlKaizen (PDCA, 4W1H, Cause and Effect analysis (C-E), Root Cause Analysis (RCA), 5S)Six-Sigma (DMAIC)
Affiliations
Handbook of thermoplastics, 2nd Edition; Co-authorship of ch.2 – Vinyl Alcohol Polymers.
ISBN 9781466577220 by CRC Press.
Green Belt, Six Sigma certification by American National Standards Institute (ANSI).
Timeline
Engineering Manager
Alphatec Spine, Inc
10.2021 - Current
Senior Packaging Engineer
Alphatec Spine, Inc
10.2018 - 10.2021
Senior Development Engineer
NuVasive, Inc
02.2016 - 09.2018
Application Specialist
TechNova Imaging Systems Pvt. Ltd
08.2010 - 07.2013
Master of Science - Packaging Science
Rochester Institute of Technology
Bachelor of Engineering - Printing Engineering
University of Pune