Kashmira Bhosale
Santa Rosa,TX
Summary
Knowledgeable biomedical professional with strong background in medical device regulations and quality control. Skilled in developing regulatory documents, procedure writing, project planning and execution.
Overview
9
9
years of professional experience
Work History
Mechatronics Engineer
Tata Elxsi
03.2022 - Current
- Labeling & Packaging experience in EU MDR
- Expertise in Regulation EU MDR 2017/745, EU IVDR 2017/746, ISO 15223-1, ISO 15223-2, ISO 20417
- Hands on experience in Agile MAP, Prisym 360, Smartsheet, MS Project
- Good in collaboration with SMEs and cross-functional team - - query resolution, project execution, project management
- Planning, assisting and aiding for desktop audits activities for Class I, Class II products.
- Planning and execute implementation activities such as creating labels specific to manufacturing site requirements, execute test prints for final labels, compiling inputs required for EUDAMED by co-ordinating with manufacturing sites and understanding the requirements
- Experience in Standard operating procedure (SOP), work instruction writing
- Planning and execute implementation activities such as creating labels specific to manufacturing site requirements, execute test prints for final labels, compiling inputs required for EUDAMED by co-ordinating with manufacturing sites and understanding the requirements.
Senior Engineer
Tata Elxsi
07.2018 - 03.2022
- Labeling & packaging experience in Regulation EU 2017/745, EU IVDR 2017/746, ISO 15223-1, ISO 15223-2, ISO 20417
- Hands on experience in Agile MAP, Prisym 360, UPV, Smartsheet, MS Project
- Experience in Technical File creation, Risk Management (RMP, RMR, AFMEA, DFMEA and PFMEA), Usability Files, DOC, IFU, PMCF
- Experience on Root Cause Analysis (RCA) and CAPA. Good understanding on DMAIC process
- Skilled in resource planning, task allocation, effort estimation, project planning and strategizing
Research Intern
Narayana Hrudayalaya Hospital
08.2017 - 04.2018
- Creating topographic graphs from tomographic images and analyzing curvature and Zernike using MATLAB image processing tool, ANYSIS and ABAQUS.
- Calculating wavefront aberrations using Zernike analysis using MATLAB image processing tool.
Sales & Service Engineer
Unique Diagnostics
11.2014 - 02.2015
- Troubleshooting of pathology instruments in path labs and hospitals
- Sales of pathology instruments
Education
Masters in Technology - Biomedical Engineering
Vellore Institute of Technology
Vellore, India04.2018
Bachelor of Engineering - Biomedical Engineering
Watumull Institute of Engineering
Mumbai, India04.2014
Skills
- Labeling & Packaging EU MDR & IVDR Regulatory compliance
- Project Planning
- Documentation coordination
- Root Cause Analysis
- Cross-functional collaboration
Timeline
Mechatronics Engineer
Tata Elxsi
03.2022 - Current
Senior Engineer
Tata Elxsi
07.2018 - 03.2022
Research Intern
Narayana Hrudayalaya Hospital
08.2017 - 04.2018
Sales & Service Engineer
Unique Diagnostics
11.2014 - 02.2015
Masters in Technology - Biomedical Engineering
Vellore Institute of Technology
Bachelor of Engineering - Biomedical Engineering
Watumull Institute of Engineering
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