Rohit Sankhe
@rohitsankhe
I am an experienced packaging engineer specializing in medical device packaging, validation, and cross-functional integration.
United StatesWhat I'm looking for
I am a packaging engineer focused on medical devices, driven by packaging innovation, precision engineering, and cross-functional collaboration. I have led acquisition integrations, reduced packaging defects through continuous improvement, and authored validation protocols meeting ISO 11607, ASTM, ISTA, and FDA expectations.
I apply materials science, FEA and hands-on machining experience to troubleshoot failures, optimize packaging performance under sterilization and distribution conditions, and manage physical testing with external labs. I collaborate across Quality, Regulatory, R&D and Operations to ensure scalable design transfer and regulatory-ready documentation.
Experience
Work history, roles, and key accomplishments
BSLed packaging validation and integration for newly acquired medical device lines, ensuring ISO 11607 and FDA compliance and reducing packaging defects through continuous improvement initiatives. Authored validation protocols and managed distribution simulation and physical testing to improve packaging reliability.
BDPerformed calibration, maintenance, and troubleshooting of packaging equipment and authored ASTM/ISTA test protocols while supporting FAT/SAT and IQ/OQ validations. Led peer training, maintained CMMS records, and implemented corrective actions to support FDA and ISO audit readiness.
Design Engineering Intern
Omkar Engineering Enterprises
May 2019 - Jul 2019 (2 months)
Designed and developed components using SolidWorks and AutoCAD and performed FEA to verify structural integrity while preparing technical documentation and operational procedures. Assisted in troubleshooting and maintenance of machining equipment.
Design Engineering Intern
Omkar Engineering Enterprises
May 2018 - Jul 2018 (2 months)
Supported design and development projects using CAD software and participated in installation and calibration of machining tools. Assisted in creating technical documentation and training materials to support manufacturing processes.
Education
Degrees, certifications, and relevant coursework
NUNorthern Illinois University
Bachelor of Science, Industrial Management and Engineering Technology
Activities and societies: Life Cycle Project — Apple (Smart) Pencil 3; Table Clamp; coursework and projects using CAD, FEA, and 3D printing.
Completed a Bachelor of Science in Industrial Management and Engineering Technology at Northern Illinois University, covering CAD, manufacturing processes, and engineering technology.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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