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 SKILLSundefined
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
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