Sanjana Kishan Singh
Medical Device Engineer Project Manager at Global Center for Medical Innovation (GCMI)- Claim this Profile
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English Full professional proficiency
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Hindi Native or bilingual proficiency
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Kannada Native or bilingual proficiency
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French Elementary proficiency
Topline Score
Bio
Sumedh Kaulgud
Detail-oriented is the word that comes to mind when I think about Sanjana. I have had the opportunity of knowing her for over a year while she worked as a System Engineer at Sattva MedTech. I was impressed by her ability to learn quickly and she contributed to a wide range of activities such as hardware and software development, testing, documenting system test protocols, risk management and continuous improvement of the device. She has also contributed heavily in building the quality management system along with experts in the field and was diligent in maintaining integrity of the system. She is highly motivated and has shown willingness to do any task assigned to her. She is a great team player who works well even in cross-functional teams. I believe that she would be a valuable asset to any team she joins. It was a joy to work with her.
Saravanan A
Sanjana Kishan Singh was a passionate and hard working intern who was sure of what she wanted in terms of her higher education and career. She was an active learner and listener whose contribution in QMS establishment is truly commendable.
Sumedh Kaulgud
Detail-oriented is the word that comes to mind when I think about Sanjana. I have had the opportunity of knowing her for over a year while she worked as a System Engineer at Sattva MedTech. I was impressed by her ability to learn quickly and she contributed to a wide range of activities such as hardware and software development, testing, documenting system test protocols, risk management and continuous improvement of the device. She has also contributed heavily in building the quality management system along with experts in the field and was diligent in maintaining integrity of the system. She is highly motivated and has shown willingness to do any task assigned to her. She is a great team player who works well even in cross-functional teams. I believe that she would be a valuable asset to any team she joins. It was a joy to work with her.
Saravanan A
Sanjana Kishan Singh was a passionate and hard working intern who was sure of what she wanted in terms of her higher education and career. She was an active learner and listener whose contribution in QMS establishment is truly commendable.
Sumedh Kaulgud
Detail-oriented is the word that comes to mind when I think about Sanjana. I have had the opportunity of knowing her for over a year while she worked as a System Engineer at Sattva MedTech. I was impressed by her ability to learn quickly and she contributed to a wide range of activities such as hardware and software development, testing, documenting system test protocols, risk management and continuous improvement of the device. She has also contributed heavily in building the quality management system along with experts in the field and was diligent in maintaining integrity of the system. She is highly motivated and has shown willingness to do any task assigned to her. She is a great team player who works well even in cross-functional teams. I believe that she would be a valuable asset to any team she joins. It was a joy to work with her.
Saravanan A
Sanjana Kishan Singh was a passionate and hard working intern who was sure of what she wanted in terms of her higher education and career. She was an active learner and listener whose contribution in QMS establishment is truly commendable.
Sumedh Kaulgud
Detail-oriented is the word that comes to mind when I think about Sanjana. I have had the opportunity of knowing her for over a year while she worked as a System Engineer at Sattva MedTech. I was impressed by her ability to learn quickly and she contributed to a wide range of activities such as hardware and software development, testing, documenting system test protocols, risk management and continuous improvement of the device. She has also contributed heavily in building the quality management system along with experts in the field and was diligent in maintaining integrity of the system. She is highly motivated and has shown willingness to do any task assigned to her. She is a great team player who works well even in cross-functional teams. I believe that she would be a valuable asset to any team she joins. It was a joy to work with her.
Saravanan A
Sanjana Kishan Singh was a passionate and hard working intern who was sure of what she wanted in terms of her higher education and career. She was an active learner and listener whose contribution in QMS establishment is truly commendable.
Credentials
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Certificate of Training: Awareness on ISO 13485:2016 Standard and Internal Audit Training for Medical Device Industry
TÜV Rheinland Asia PacificJan, 2017- Sep, 2024
Experience
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Global Center for Medical Innovation (GCMI)
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Medical Device Engineer Project Manager
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Aug 2018 - Present
• Lead a team of engineers in the development of a vascular balloon catheter including interacting with clients, physicians, and production team to communicate project progress and manage expectations.• Lead a team of 2 engineers to manufacture a 3D printed surgical instrument.• Contribute as a R&D engineer to development of novel medical devices such as a 3D printed implantable, microneedle patch, and an intermittent pneumatic compression device.• Collaboratively develop engineering specifications based on user needs and engineering requirements.• Proficient in executing and completing design risk analysis for medical devices projects (FMEAs, risk reports).• Verify and validate key design inputs including functional, reliability, performance, & usability requirements.
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Product Development Intern
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Nov 2017 - Jul 2018
• Created a process to navigate design requirements with respect to regulatory standards (esp. IEC 60601)• Assisted in translating design input requirements into product design while meeting required regulatory standards (esp. IEC 60601 and Risk Management ISO 14971)
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Sattva MedTech
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India
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Medical Equipment Manufacturing
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1 - 100 Employee
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System Engineer
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Jun 2016 - Jul 2017
• Medical Device Start-up focusing on child and maternal healthcare. Building a next generation fetal distress monitor to address 300,000 annual perinatal deaths.• Developed system and subsystem requirements for FetalLite™, next-gen fetal heart rate, and uterine contraction monitor.• Planned, developed and documented test methods to assess performance of hardware subsystem requirements.• Independently developed a feedback probe using BLE Nanotechnology (standalone accessory) that was used to communicate to a software application.• Performed data analysis on fetal heart rate, maternal heart rate and uterine contraction to assess noise levels.• Traveled within assigned regions to train nurses about the proper clinical usage of the product.Performed specific tasks in compliance with ISO 13485:2016: • Collaboratively developed an efficient Quality Management System (QMS). • Performed risk analysis of Class IIa (EU) medical device as per ISO 14971:2016. • Developed system V & V by creating and reviewing test protocols and managed execution of the same. • Participated in an internal audit of the quality management system (successfully audited section 4.1 of ISO 13485:2016) • Responsible for day-to-day administration of the QMS and in the development, implementation, and maintenance of QMS processes to meet the requirements of ISO 13485:2016. • Ensured successful regulatory submission for Sattva MedTech. (ISO 13485:2016 and CE)
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InnAccel
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India
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Medical Equipment Manufacturing
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1 - 100 Employee
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Product Development Intern
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Aug 2015 - Apr 2016
• Project Name: A Platform to detect characteristics of secretions Designed and implemented a power management module, sensor data acquisition system with the integration of pump and driver circuit to effectively perform characterization analysis of simulated secretions to aid in early diagnosis of Ventilator Associated Pneumonia• Project Name: Aawaaz, Neonatal hearing screening device Led extensive research efforts to establish the unmet need of: An Objective and Reliable Behavioral Audiometry Electronic Device to Screen Newborns for Hearing Loss in Resource Constrained Settings.
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Philips Innovation Campus, Bangalore
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Research
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1 - 100 Employee
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Intern
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Jan 2015 - Feb 2015
• Successfully identified and reported bugs while testing the software performance of 1.5T MRI system • Successfully identified and reported bugs while testing the software performance of 1.5T MRI system
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Education
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2017 - 2018
Georgia Institute of Technology
Master's degree, Biomedical Innovation and Development -
2012 - 2016
B. M. S. College of Engineering
Bachelor’s Degree, Biomedical/Medical Engineering
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