Nabil Khan Email and Phone Number
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Biomedical Engineer by training with an emphasis in bioinstrumentation, computational modeling/numerical methods, and human anatomy and physiology.Systems and Software Engineer by profession with an exclusive focus on medical devices. Significant experience leading and executing embedded systems and software design and development efforts across a variety of medical device product codes and classifications (Class I/II Devices with IEC 62304 Class A, B, and C Software Systems), the majority of which are new product designs.Major involvement across all phases of software development life cycle, including very proactive roles in requirements gathering, risk management activities (DFMEAs, Process FMEAs, Safety Assurance Cases), and development/test/VnV planning activities, with corresponding documentation generation.My design and development experience is primarily focused on Embedded Software Systems implemented in C/C++. Extensive experience from low to high level code development and testing, including low-level drivers, custom GUI frameworks, multiDOF motion control, and other moderate-complexity control systems. Proficient in Several Critical Standards/Guidelines for Medical Device Software Development, including:- IEC 62304:2015 (especially concerning Class B and C Systems)- ISO 14971:2019/24971:2020- ISO/TIR 80002-1:2009 Application of Risk Management for Medical Software- ISO 13485:2016- ISO 60601 Collateral and select Particular standards- 21 CRF 820- FDA Software Related Guidances to Industry (Software Validation, OTS, Cybersecurity, Premarket Submissions etc)I’m very interested in growing/leveraging my skills and experience to develop and commercialize novel technologies to the Medical Device Space. I am a strong believer in strong requirements engineering and structured, methodical problem solving, with an emphasis on approaching design/development challenges from a risk-based perspective.
Theia Imaging
View- Website:
- theiaimaging.com
- Employees:
- 8
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Theia ImagingChapel Hill, Nc, Us
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Director Of Product DevelopmentTheia Imaging Sep 2024 - Present
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Principal Systems EngineerTheia Imaging Mar 2023 - Present
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Senior Software Systems EngineerTitan Medical Inc. Jan 2022 - Feb 2023Toronto, Ontario, CaSoftware System Engineer for NPD IEC 62304 Safety Class C Robotic Assistive Surgery Software System. Robotic System comprised of 7 multicore MCUs interconnected with DDS databus to provide single port dual instrument laparoscopy.- Lead Software Risk Management effort to identify adequate risk mitigation and ensure a fault tolerant design in a highly complex software system- Lead Software Requirements Management effort to assure requirement alignment between Enos System and Enos Software, and within the Enos Software System across each decompositional level (Software System/Items/Units)- Lead Software Configuration Identification/Management effort for 50+ target configuration item(including 20+ SOUP/OTS items)- Provided medical software quality/regulatory expertise to inform development strategy as developmentteams transitions into design-controlled development- Worked closely with software and non-software product development leadership across organization tochoreograph development milestones for successful FDA submissions -
Design & Prototype EngineerUniversity Of North Carolina At Chapel Hill School Of Medicine Jan 2019 - Jan 2022Chapel Hill, Nc, UsMedical Software/Electronics Engineering specialist for FastTraCS, a medical device innovation group which focuses on supporting Clinician Innovators in developing and maturing nascent academic medical technologies for patenting,licensing, and commercialization.- Designed and prototyped novel medical technology solutions to validated clinical unmet needs across UNC Health System.- Provided medical electrical systems, medical software, and regulatory expertise to advance and successfully position medical technology designs to smoothly transition into design controlled medical product development- Identified, observed, and validated unmet clinical needs across several departments and divisions of UNC Health, including Hospital Medicine, Minimally Invasive Gynecological Surgery, ENT, Vascular Interventional Radiology, etc -
Advanced Embedded Software EngineerTechnosoft Innovations Inc. Jun 2017 - Jan 2019Morrisville, Nc, UsLead Software Engineer across all phases of product development cycle to deliver IEC:13485 Compliant medical devices to US Medical Customers for Contract Design House. Lead RTP and Offshore Software Delivery Team* Software lead for RFQ effort estimation and preliminary design for customer proposals* Technical Lead for requirements gathering, risk management, and software testing activitiesMajor Projects include:- Cryogenic Compressive Therapy Device (NPD - FDA Class IIB 510k)o Designed closed loop control system for TEC based heat/cool control, compression control for ARMCortex M4+o Developed custom GUI C++ Widget Framework to support touch interface on Integrated Display- Electrical Stimulation Device (NPD – FDA Class IIA De Novo)o Developed HAL, App Code for firmware on STM32LX ARM Cortex M0+- Noise Cancellation Incubator Device (NPD – FDA Class IIB De Novo)o Software Design for Dual Processor System (Cortex M4+ and ADI BF5XX Fixed Point DSP)o Developed Firmware for DSP responsible for Audio H/W Interface and Signal Processing Algorithm- Technosoft Internal QMSo Acted as Interim Quality Manager for 2017 Q4 thru 2018 Q1, and trained replacement QEo Represented Technosoft Innovations quality system during BSI audit for IEC 13485:2016 compliance inMarch 2018o Software Quality Lead for organization -
Embedded Software EngineerTechnosoft Innovations Inc. Jun 2016 - Jul 2017Morrisville, Nc, Ussoftware developer lead role across all phases of product development cycle to deliver IEC:13485 Compliant medical devices for Contract Medical Design House.Major Projects include:- Anesthesia Injection Drug Delivery Device (FDA Class IIC)o Lead Development Effort to add Features, monitor and resolve software defects on PowerPC platformrunning Windows CE/ Embedded 7 interfacing with AllMotion Stepper Controllerso Multithreaded Applications using MFC and Win32 APIo Lead project specific efforts to comply with FDA Total Life Cycle Guidance for Infusion Pumps, includingIEC60601 specific h/w and s/w features; Safety Assurance Case risk management- TENs and Ultrasonic Therapy Device (FDA Class IIB)o Lead reverse engineering/porting effort for obsolescent processor to ARM A9o Developed new features to comply with new IEC 60601 regulatory requirements (alarm systems,usability)- Technosoft Internal QMSo Software Quality Lead for organization – responsible for updating QMS controls and processes to become compliant with IEC 62304 configuration management, software testing, and software artifactrequirements
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Embedded Software EngineerAnuva Innovations (Formerly Trie Medical) Sep 2013 - May 2016Morrisville, Nc, UsDeveloped medical firmware for embedded systems. Participated in all phases of product development cycle to deliver IEC:13485 Compliant medical devices for Contract Medical Design House.Major Projects include:- Inductive Heating Cancer Therapy Device (NPD - FDA Class IIB De Novo)o Designed and implemented high- and low-level code for non-contact thermal control system, coolingcontrol system, and motion control interface systemo Design and implemented interface for 5DoF Galil Motion Controller responsible for Robotic Arm movement -
Graduate Research AssistantNorth Carolina State University Aug 2010 - Sep 2013Raleigh, North Carolina, Us• Developed a computer-based theoretical framework to model and explore prototype/current assistive lower-limb rehabilitation technologies• Characterized human kinematics, joint forces, joint powers, and energetics to inform and refine assistive device design direction and implementation• Extensively utilized MATLAB to simulate muscle-tendon dynamics of healthy human ankles, ankles configured with a pneumatic muscle, and ankles configured with clutched-spring assistance• Gained proficiency in Multi-Objective Optimization Methods, ODE Solvers, Digital Filtering Techniques, and other applied numerical methods. -
Microcontrollers Teaching AssistantNorth Carolina State University Aug 2012 - May 2013Raleigh, North Carolina, Us• Assisted in lecture and project portions of BME 481 – Biomedical Microcontroller Applications• Covered hardware architecture, machine code, lower-level and upper-level languages, I/O, and analog/digital transducer and sensor interfacing• Introduced and guided datasheet interpretation, driver development, board prototyping, and structured troubleshooting methodology• Individually graded every ASM and C language program assignment and project• Developed ability to quickly interpret, comprehend, and critique third party code, improved grasp on syntax/ structuring strategy, and gained additional experience with sensor/device prototyping
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Solidworks Teaching AssistantNorth Carolina State University Aug 2010 - May 2013Raleigh, North Carolina, Us• Primary course instructor and administrator for BME 252 – SolidWorks Modeling• Individually managed, graded, and created supplemental course content for over 125 engineering students• Taught basic to intermediate solid modeling topics, introductory DFMA techniques, and introductory FEA • Developed a robust, high-level understanding of the SolidWorks development environment, as well as efficient troubleshooting strategies
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Avid S.T.E.M. Supplemental InstructorChapel Hill-Carborro City Schools Sep 2011 - Jun 2012• Supplemental instruction leader for over 110 students in science and mathematics courses for middle and high schools classes participating in AVID National Curriculum program• Taught mathematics content ranging from Math 6 to Calculus BC, and sciences content ranging from Science 6 to AP Chemistry, AP Biology, and AP Physics• Gained strong interpersonal skills and ability to communicate with people of diverse backgrounds and different competency levels
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Research AssistantUniversity Of North Carolina At Chapel Hill Mar 2009 - Sep 2009Chapel Hill, Nc, Us• Assisted in creating a system that provided real-time quantitative feedback to surgeons when placing and securing an implanted surgical chest bar in patients with moderate to severe pectus excavatum• Characterized deflection pattern and compressive stress and strain properties of Lorenz © Pectus bar• Designed custom circuitry and constructed a testing rig to mimic thoracic cage and produce physiologically relevant pressures• Collaborated closely with Dept. of Pediatric Surgery to improve testing procedures and system development -
Research AssistantUniversity Of North Carolina At Chapel Hill May 2008 - Sep 2009Chapel Hill, Nc, Us• Analyzed PET and SPECT scans of thyroid patients treated with radiation agent and FDG to determine effective dose absorbed in tissue• Used IDL© MIAU and 3D-ID image analysis software packages • Created a UNC system-wide database that compiled nuclear medicine patient records and prognoses for future studies
Nabil Khan Skills
Nabil Khan Education Details
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North Carolina State UniversityBiomedical/Medical Engineering -
University Of North Carolina At Chapel Hill School Of MedicineBiomedical/Medical Engineering
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University Of North Carolina At Chapel HillBiomedical/Medical Engineering
Frequently Asked Questions about Nabil Khan
What company does Nabil Khan work for?
Nabil Khan works for Theia Imaging
What is Nabil Khan's role at the current company?
Nabil Khan's current role is Medical Device Development Specialist.
What is Nabil Khan's email address?
Nabil Khan's email address is na****@****inc.com
What schools did Nabil Khan attend?
Nabil Khan attended North Carolina State University, University Of North Carolina At Chapel Hill School Of Medicine, University Of North Carolina At Chapel Hill.
What are some of Nabil Khan's interests?
Nabil Khan has interest in Education/outreach, Global Health Engineering, Medical Device Development.
What skills is Nabil Khan known for?
Nabil Khan has skills like Embedded Systems, C/c++, Medical Device Software Development, Software Risk Management, Software Testing, Software Verification And Validation, Medical Device R&d, Iec 62304, Iso 14971, Iec 60601, 21 Cfr 820, 21 Cfr Part 11.
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