Tejashree Hemant Pingale

Risk Analysis | Production Support | Automation & Scheduling | Database Management | Client Relationship Management

JOB OBJECTIVE PROFILE SUMMARY

As new technologies emerge, aiming to
expand expertise and apply it to a
profession with mutual growth in the field
of Medical devices sector
CONTACT
tejashree.pingale@yahoo.com
https://www.linkedin.com/in/
tejashree-pingale-102bb951
+91- 9404192988 / 7972482703
CORE COMPETENCIES
 Highly professional with more than 5 years of rich experience in managing project
deliveries with the Medical / Healthcare sectors
 Generated Regulatory Compliance documents for Medical Devices of Class I to Class
III as per EU-MDR along with ISO standards such as, ISO 13485, ISO 10993-1, ISO
14971
 Received exposure in software testing of medical devices while pursuing the
internship with Moog India Technology Centre (Medical Division) Pune
 Successfully delivered customer centric output on Medical Devices study & their
analysis
 Executed time and cost saving projects including automation of GSPR
 Interacted and negotiated with clients for follow-up on unresolved issues, analyzed
and resolved problems, performing due-diligence, system study & analysis, reporting;
effective in ensuring high-quality customer satisfaction while adhering to the work
processes
 An effective communicator with distinguished skills in motivating and training team
members for successful process operations

 Strategy Planning WORK EXPERIENCE

 Regulatory Documentation(EU-MDR)
 Product Risk Assessment TATA Elxsi, Pune as Senior Engineer, Since Mar’19
 Project Leader Key Result Areas:
 Project Deliveries  Putting efforts in planning and estimating required to deliver the system
 Liaising & Coordination  Participating in discussions regarding attaining quarterly targets
 Client Interactions  Creating gap analysis of MDD documents with respect to EU-MDR
 Vendor Management  Managing & maintaining PM documents and facing Internal & External Quality audits
 Mentoring & Knowledge sharing  Authoring & reviewing of documents like risk analysis, product description, GSPR, list
 Estimations & cost control of applicable standards, CDS forms, Biocompatibility report, CMR form, Verification
and Validation testing documents, etc. for class I to class III medical devices
SOFT SKILLS
Cummins India Limited, Pune as Sourcing Analyst , Sep’13 – Aug’15
 Motivator
Key Result Areas:
 Communicator
 Contributed towards various cost saving projects
 Team-player
 Managed the Purchase orders of the suppliers & Price Change Requests
 Leadership
 Made some supplier visits
 Analytical
 Interpersonal
INTERNSHIP DETAILS
IT SKILLS
 Moog India Technology Centre (Medical Division) Pune in Sep’17 – Aug’18
 Developed workflows, test cases & test scenarios and tested them as per customer
 Oracle ERP
Defined requirements in manual testing of “next generation home care infusion
 SAP
pumps”
 Helix ALM/Surround SCM
 Identified defects with the end to end testing
 Test Track
 Maintained traceability matrix for all the test cases
 MS-Office
 Defect logging, Retesting, Regression testing
 JIRA
 BDoCS (Client Document  Cummins India Limited Pune in May’12 – Jun’12
Management Tool)
 Studied Fault-Tree Analysis of Fuel Conditioning Unit and Combustion Air Handling
Unit
PERSONAL DETAILS
th
Date of Birth: 7 November 1991
Languages: Marathi (Native), English,
Hindi, German
Address: B16, Akshay Park Society,
Aundh-Ravet Road, Near McDonalds,
Thergaon, Pune- 411033
ACHIEVEMNETS
 Achieved the “Project Excellence Award” in TATA ELXSI for Value Added Services in
the project “EU MDR Compliance Program Phase II+”
 Achieved the Bravo Award in TATA ELXSI for “Understanding and Meeting Customer
Expectations Throughout the Challenging Review phase and dedicatedly worked as
Project CC to maintain Quality Standards”
 Awarded with Certificate for Delivering Superior Results in achieving target saving in
ACE Program III at IEBU in Cummins India Limited
EDUCATION
 Post Graduate Degree in Biomedical Instrumentation Engineering from MKSSS’s
Cummins College of Engineering for women, Pune with 8.57CGPA in 2017
 Bachelors in Instrumentation & Control Engineering from MKSSS’s Cummins College
of Engineering for women, Pune with 66.2% in 2013
 XII (MSB) from Z. B. Patil College, Dhule with 87.1% in 2009
 X (MSB) from K. S. Girls High School, Dhule with 88.61% in 2007
CERTIFICATIONS
 Six Sigma Certified from Cummins India Limited
 Udemy Certificate of “EU Medical Device Regulatory Affairs Explained Simply”
completed in June 2021
 Udemy Certificate of “ISO 13485:2016 – Design and Development of Medical
Devices” completed in July 2021
 Yoga Certification from “Yogvidya Gurukul, Nashik”
ACADEMIC WORK
 M.E. Project- Pneumonia Diagnosis using Cough Sound Analysis
 B.E. Project- Automation of Gasket Laying Machine byATmega8535
 T. E. Mini Project- To Measure Cardiac Pulse Rate using Finger Photo
Plethysmography
PAPER PUBLICATIONS
 ‘Analysis of Cough Sound for Pneumonia Detection’, presented in ‘Third International
Conference on Research Trends in Engineering, Applied Science and Management
(ICRTESM-2017)’, at IETE Pune, ISBN: 978-81-934083-1-5, on 28 May 2017
 In Third International Conference on Computing, Communication, Control And
Automation (ICCUBEA) 2017, at PCCOE Pune