SANDHYA KOTA

**** ******** ****, ***** ****, OH-*3064 510-***-**** adbkp2@r.postjobfree.com

Professional Summary

Experienced Chemical Engineer with 4+ years of experience in New Product Development and manufacturing high quality functional products under GMP guidelines and leading projects throughout the product lifecycle in accordance with FDA regulations. Passionate about studying current customer trends and improving cost-efficient products.

Core Skills: Product Development IQ/OQ/PQ Good Manufacturing Practices Manufacturing Leadership Interpersonal skills Project Management Design controls Trouble shooting Protocol/Reports Technical Writing Project Management Microsoft Project Minitab Packaging validation Agile Product Lifecycle Mgmt

Chemical Core skills: Scanning Electron Microscopy (SEM) Gas Chromatography (GD) Thermogravimetric Analysis (TGA) Fourier Transform Infrared Analysis (FTIR) High Performance Liquid Chromatography (HPLC)

Continuous Improvement Tools: Statistical Data analysis and Process Control Quality Control Kaizen Data Analysis DMAIC Lean Six Sigma DFMEA pFMEA ISO procedures

Work History

R&D Engineer -Product Development 07/2017 to Current

CARDINALHEALTH – CHICOPEE, MA

Successfully launched a Class II medical devices product that allows Cardinal Health to increase its overall sales in the US market.

Developed a product which increases the re-usability and reduces the cost over regular ECG electrodes by 64%.

Coordinated and conducted Clinical design verification & validation studies to collect data regarding the safety and efficacy of the new product development for FDA approval.

Supported regulatory and marketing team with medical device labeling to meet FDA and international requirements. (MDR conditioning, MRI, CE).

Monitor and report process and plant development activity to assure conformance to established engineering and manufacturing standards and performed pFMEA, DFMEA, and Risk Analysis as part of New Product Development process.

Collected and analyzed research data necessary for building marketing strategies and claims substantiation.

Managed functional teams (Legal, Regulatory, Clinical Affairs, Marketing, Quality, etc.) and made strategic decisions to overcome the project challenges.

Experience of communicating with various stakeholders like business teams and development teams for requirement analysis, development and testing activities.

Experience in creating first article inspection (FAI) document prior to product launching.

R&D Engineer 11/2016 to 07/2017

MEDTRONIC – (Acquisitioned by cardinal Health) CHICOPEE, MA

Efficient in handling Product Data, records, DHFs in Agile for better traceability.

Responsible for preparing standard Engineering reports, protocols and presentations as required to document and communicate results.

Lead sterilization study on packaging material of ECG electrodes according to the ANSI/AAMI Standards

Conducted testing in Class II medical devices/disposable products to ensure the product meets FDA requirement.

Instrumental in performing budget specific cosmetic gel applications in conjunction with Marketing and external customers.

Quality Engineer 05/2016 to 10/2016

STRYKER CORPORATION – KALAMAZOO, MI

Developed training protocols in alignment with company quality standards and ISO 9000 regulations.

Built strong rapport with team members, management and clients to facilitate efficiency and productivity.

Handling customer queries and ensuring customer satisfaction by providing effective services.

Responsible for running and supporting Engineering study on various surgical products.

Involved in Developing Medical Device risk management documentation.

Process Design Engineer 08/2009 to 07/2011

SRICHEM CONSULTANTS

Provided process engineering support on client’s issues which significantly increased the process productivity.

Proposed steps for reducing the downtime of metal fabrication process.

Maintained product specifications that reflect customer requirements.

Handled various machinery processes in plant and prepared layouts using various designing tools. Generated reports, analyzed data, identified problems and reconciled corrections.

Attained experience in manufacturing equipment, troubleshooting, reliability and design optimization.

Education

MS: Project Management Current

University of Cumberland's - Kentucky

Master's: Chemical Engineering Dec 2015

Illinois Institute of Technology - Chicago

Master of Science: Chemical Engineering (Petroleum) June 2013

Anna University - India

Bachelor of Science: Chemical Engineering June 2009

RVR&JC College of Engineering - India

Accomplishments

Managed a cross functional team, design and develop a new monitoring ECG electrode that is less time consuming and reduce wastage in the Hospitals.

Certifications

DMAIC- Six-Sigma Problem Solving Tool

Implementing Design Controls Requirements and Best Practices

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