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APARAJIT SAHAI

** ******** ******, **** ****, Toronto, Ontario, Canada M4Y 1M8

adba17@r.postjobfree.com Phone: +1-437-***-****

Languages: English, Hindi, Basic German

Profile

Expertise in medical device regulations, quality management system and testing. Skills

Med. Device

Regulations

510(k),

ITA,

MDL

Supplier

Audits

Quality

Management

Systems

Internal

Audits

Rapid

Prototyping

MS Office

suite

Adobe Creative

Suite

Education

Rotman School of Management, ON, Canada Sep 2019 - May 2022 MBA-Part Time, Ongoing

University of Toronto, Toronto, ON, Canada Sep 2016 - Aug 2017 Master of Engineering, Biomedical Engineering (with a focus on design, development and commercialization of biomedical devices), CGPA 3.77/4 SRM University, Chennai, India Aug 2012 - May 2016 Bachelor of Technology, Biomedical Engineering, CGPA: 9.6/10 Work History

o Flosonics Medical April 2018- Current

Quality Engineer & Regulatory Affairs Associate

• Develop Design Control documents in accordance with ISO 13485, IEC 62304, ISO 14971

• Prepare regulatory submissions for FDA, Health Canada, Europe and other jurisdictions

• Prepare 510 (k) submissions for Class II products, Health Canada Licence applications for Class II and Class III medical devices, ITAs for Health Canada and CE Technical File.

• Develop test plans in accordance with product profile and IEC 60601-1, applicable collateral, and particular standards

• Conduct verification and validation activities for medical devices

• Write and maintain quality control documentation.

• Responsible for the implementation of the QMS in accordance with ISO 13485 and other applicable regulations

• Responsible for conducting supplier audits, interfacing with suppliers and monitoring supplier performance

• Responsible for providing assistance in manufacturing operations o Ironstone Product Development September 2017- March 2018 Associate Medical Device Consultant

• Develop Design Control documents in accordance with ISO 13485, IEC 62304, ISO 14971

• Prepare regulatory submissions for FDA, Health Canada, Europe and other jurisdictions

• Prepare 510 (k) submissions for Class II products, Health Canada Licence applications for Class II and Class III medical devices, ITAs for Health Canada and CE Technical File.

• Develop test plans in accordance with product profile and IEC 60601-1, applicable collateral, and particular standards

• Conduct verification and validation activities for medical devices

• FDA Laser Registration

• Authored successful Class III Health Canada Applications

• Authored and reviewed 510(k) submissions, Health Canada Applications o Ironstone Product Development May 2017- August 2017 Intern

• Developed a pre-clinical test plan for an ophthalmic laser product. 2

• Aided in the development of a Risk Analysis for an ophthalmic laser product.

• Developed design control documentation for a light therapy device to treat Alzheimer’s. a) Requirements Document

b) Verification and Validation Test Procedures

c) Conducted Verification and Validation for the device.

• Developed design control documentation for a hematoma detection device. a) Requirements Document Verification and Validation Plan b) Conducted Verification and Validation for the device. o Cells for Life March 2017- October 2017

Customer Service Representative (Weekend Part-time) o Gen Academy September 2016- March 2017

Instructor (Part-time)

• Taught math, physics, chemistry, and science to students from grade 7-12 for 100+ hours o Khademhosseini Lab, Brigham and Women’s Hospital, Boston November 2015 - March 2016 Research Trainee

• Developed a prototype for a hydrogel extruder. Used python and raspberry pi to program pneumatic valves to enable synchronized extrusion of hydrogels.

• Developed a prototype for a robotic hydrogel delivery system. Used servomotors programmed with an Arduino to guide a catheter prototype.

• Fabricated various PDMS chips for lab experiments. o Department of Applied Mechanics, IIT Madras, Chennai, India May - July 2015 Intern

• Worked on an electronic glove to replace a keyboard designed for a specific experiment. Used the teensy (Arduino variant) for the glove interfaced with various touch sensors

• Researched and helped the lab choose a suitable motion capture system.

• Aided in the testing and installation of a highly sensitive accelerometer and helped write the LabView code for the same.

o Dr. Agarwal’s Eye Hospital, Chennai, India 2 weeks, July 2014 Intern

• Worked in the imaging department and was introduced to various imaging modalities used in Ophthalmology. Focused mainly on the OCT machine.

• Was introduced to the operations of the hospital.

• Was briefly introduced to all the various lasers used in ophthalmic treatments. Project Experience

o Hydrogel Extrusion Device

• Used a Raspberry Pi to program pneumatic valves to control the extrusion hydrogels.

• Hydrogels were extruded from multiple channel. The raspberry controlled the opening and closing of the valves that controlled these channels. o Robotic Hydrogel Delivery System

• Developed a proof of concept prototype of a robotic catheter for in-vivo 3D bio-printingof hydrogels.

• The Arduino Mega was used to program servo motors that controlled guide wires that ran through vertebrae that supported a flexible tube. The robot has 4 degrees of freedom.

• The robotic hydrogel extrusion device will be integrated with this delivery system in the future to enable in-vivo 3D bioprinting.

o Effects of Inversion on the N170, Department of Electrical Engineering and Department of Psychology, National University of Singapore, Singapore, January - May 2015 Team Size: 6

The project dealt with N170 component of the EEG after the presentation of inverted stimulus. It was observed that the N170 has a higher amplitude when the subject is presented with inverted faces. Such 3

observations were not made with inverted dog and car ‘faces.’ o ECG acquisition module using a NI’s ‘myRIO’ using Labview, SRM University, Chennai, November 2014

Team Size: 3

• Used the NI myRIO for acquiring signal which was then processed in Labview to obtain ECG wave.Single lead ECG configuration and disposable ECG electrodes were used.

• Amplified the signal with an AD 620 Instrumentation Amplifier before it was fed to the myRIO.

• The noise obtained was filtered to get the ECG wave. o Development of A System for the Prevention of Cluster Headaches during Sleep

• Developed a Monte-Carlo simulation

• Developed a digital controller to allow the system to deliver oxygen based on specific triggers Additional Courses

o Robotics for Human Movement Training, one week, conducted by Professor Sunil Agrawal of Columbia University, at Veermata Jijabai Technological Institute, Mumbai, August 2016 o Embedded Systems (Weekend Course), four months (part time), conducted by Indus Automation, Chennai, July - November 2014

o Biomedical System Design, 10 days conducted by National Instruments, Bangalore, November 2014 o Programming an ARM Cortex M3, 10-day online course, conducted by Technophilia, Mumbai, July 2014 o Neonatal Equipment, one-week, TriMedx, Bangalore, February 2014 o Embedded Linux for ARM, two weeks, AICRA, New Delhi, December 2015’ o Graphics, Video Editing and Animation, two-year Diploma course, Arena Animation, Moradabad,2007

- 2009

References

Available upon request.

Contact this candidate