Prashant Dalvi
Biomedical Engineer
Mumbai,Maharashtra
Summary
Biomedical Engineer with 9 plus years of experience. Seeking a challenging role in a organization wherein can apply skills and experience to drive the development of groundbreaking medical devices, improve patient care, and contribute to the company's success.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
3
3
Certifications
Work History
Senior Engineer
Tata Elxsi Ltd
Mumbai
4 2019 - Current
- Develop and maintain technical documentation as per EU MDR standards.
- Coordinate and manage creation and submission of EU MDR regulatory submissions.
- Implement and maintain quality management systems in line with EU MDR requirements.
- Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to ensure regulatory compliance.
- Working as Product Owner, successfully delivered package on End-to-End basis.
- Subject matter Expert for Design Verification and Validation & Bio-compatibility
- Deep analysis of risks associated in overall usage for Medical Device right from production to duration of use and till disposal
- Identify faults if any in packages as Expert reviewer
- Coordinate activities with cross-functional teams to meet project deadlines.
- Managed team of 10 members and successfully completed project
Junior Engineer
Immucor India Pvt. Ltd
Mumbai
05.2018 - 03.2019
- Looked forward into installations, breakdown and preventive maintenance of blood serology equipment & Luminex machines in HLA (Human Leukocyte Antigen) department
- Worked on Laboratory equipment like Centrifuge, Incubator, Pipettes, Washer etc.
- Provided technical support to customers throughout India and resolving issues over telephone, email or video call
- First to install updated Camera module in India for better results in analyzers.
- Managed team of five franchises for attending customer sites on time and for proposal creations.
- Managed around five sites per day.
Field Service Engineer
Agfa Healthcare
Mumbai
08.2015 - 04.2018
- Looked forward into installation, breakdowns and preventive maintenance of Computed Radiology, Direct Radiology systems, PACS and workstations
- Looked forward at preparing and scheduling AMC/CMC contracts
- Trained and handled team of field service Engineers as territory manager
- Done interfacing of Imaging results with various archiving and viewing software (RIS).
- Managed team of Fourteen Engineers.
- Investigated and troubleshot around 30 product service issues weekly.
Education
B.E (Bachelor of Engineering) - Bio-Medical Engineering
Mahatma Gandhi's Mission College of Engineering And Technology New Mumbai, Mumbai University
Mumbai, India 05.2009 - 05.2015
Skills
ISO 13485
- DICOM Viewers
- Web Servers
Laboratory Information System
Radiology Information System
- Microsoft office
Risk Analysis
Regulatory Affairs
Bio-compatibility
ISO 14971
EU MDR
US FDA
DHF Remediation
Project Management
Certification
Training certificate from AGFA HEALTHCARE for successful training completion.
Additional Healthcare Skills
- Serology Lab works Workflow
- Radiology Workflow
- PACS (Picture Archiving and Communication System), Product Risk assessment
- Material Biocompatibility Assessment
- Serology and HLA machines troubleshooting
- Laser Alignments
- Product understanding skills
- Careful measurement and Analytical skills
Technical Expertise
- Creation and review of technical files like Biocompatibility forms, Clinical Evaluation Reports & Product Descriptions for MDR certification of Medical Devices.
- Identifying and mitigating risks associated with Medical Devices as per standard EN ISO 14971.
- Subject matter expert (SME) for design Verification and Validation of Medical Devices and Biocompatibility.
- Resource management and delivery planning.
- Conducting a site inspection for defect free and safe installation of Radiology, Serology and HLA systems.
- Identifying gaps in Medical Device drawings.
- Troubleshooting complex technical defects in deliverables on own or in coordination with core technical team.
- Expertise on Serology and HLA machine usage workflows.
- Identifying false results in lab works due to manual or reagents faults.
- Providing applications trainings to customers with live demos for defect free and safe use.
- Identifying healthcare business problem and root cause analysis.
- Suggesting process improvement changes to mitigate the problems and conceptualizing the client specific solutions.
Accomplishments
Two times winner of "Project Excellence Award" (2021, 2022)
Extra Mile Award Winner (2023)
MDR Star Award (2024)
Disclaimer
I hereby declare that the above-mentioned details are true to the best of my knowledge.
Name & Sign
Prashant Dalvi
Timeline
Certificate for contribution in TEAMWORK from IMMUCOR INDIA PVT LTD.
11-2018
Training certificate from LUMINEX CORPORATION for successful training completion.
11-2018
Junior Engineer
Immucor India Pvt. Ltd
05.2018 - 03.2019
Training certificate from AGFA HEALTHCARE for successful training completion.
07-2016
Field Service Engineer
Agfa Healthcare
08.2015 - 04.2018
B.E (Bachelor of Engineering) - Bio-Medical Engineering
Mahatma Gandhi's Mission College of Engineering And Technology New Mumbai, Mumbai University
05.2009 - 05.2015
Senior Engineer
Tata Elxsi Ltd
4 2019 - Current
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