Maithili Kamat
Project Manager at GMED | Regulatory Affairs | AI and Software
- Role
- Certification Project Manager at GMED
- Location
- Falls Church, VA, US
- LinkedIn followers
- 500 followers
About Maithili Kamat
I am a Systems Engineer and a Technical Project Manager with over 10 years of product development experience in the medical device industry. I have a master\'s degree in Bioengineering and Biomedical engineering from Wayne State University and a Six Sigma Green Belt certification.My most recent role was at NuPulseCV, Inc. where I owned the product and execution efforts for the NuPulse Voyage next-generation device, a novel cardiovascular device that improves the quality of life for patients with heart failure. I worked closely with clinicians, engineers, and software developers to create a data-driven roadmap for product development, based on customer and business needs. I also managed a product team of six engineers, using agile project management methodologies and tools, such as Jira, to deliver high-quality outcomes on time and within budget.I have a passion for innovation and quality, and I have successfully led and managed teams and projects for various medical devices, such as heart lung machines, roller pumps, centrifugal pumps, microcontrollers, GUI, RF phased array coils, MRI imaging devices, and PET-CT hybrid machines. I have extensive skills and knowledge in customer focus planning and integration, prototyping and design, risk assessment, V&V, regulatory compliance, CAPA, and post-market surveillance activities.I am also a self-taught AI and machine learning enthusiast, and I have completed online courses in Machine Learning Specialization. I believe that behind every great product, there is a great team, and I strive to communicate, mentor, and empower my team members. I am always eager to learn new skills and technologies, and I am looking for new opportunities to apply my expertise and make a positive impact in the medical device industry.
Experience
Certification Project Manager
May 2024 — Present · Rockville, MD, US
Education
Wayne State University
Master of Science - MS, Bioengineering and Biomedical Engineering
University of Mumbai
Bachelor of Engineering (BEng), Biomedical/Medical Engineering
2007 — 2011
Skills
- Research
- Iso 13485
- C
- Programming
- Quality Assurance
- Labview
- Biomedical Engineering
- C++
- Automated Software Testing
- Research and Development (R&D)
- Matlab
- Microsoft Word
- Windows
- Java
- Microsoft Office
- System Testing
- R&D
- Medical Device R&D
- Powerpoint
- Microsoft Excel
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