Divya Maxwell

Divya Maxwell Email and Phone Number

Senior Human Factors Engineer at Intuitive @ Intuitive
Divya Maxwell's Location
San Francisco Bay Area, United States, United States
Divya Maxwell's Contact Details
About Divya Maxwell

Having worked in the medical device industry for over 10 years, I am passionate about improving patient lives by enhancing the user experience of complex medical devices. Collaborating with an amazing cross functional team, I have had the privilege to develop new user centered features for the next generation of surgical robotics systems and software applications. Through developing human factors evaluation methods, my goal is to ensure that complex medical device systems are safe and effective for use. I am knowledgeable in ISO 13485:2016, ISO 14971:2019, IEC 62366-1:2015/AMD1:2020, IEC 62366-2:2016, and FDA’s 2016 Human Factors guidance for medical devices.

Divya Maxwell's Current Company Details
Intuitive

Intuitive

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Senior Human Factors Engineer at Intuitive
Divya Maxwell Work Experience Details
  • Intuitive
    Senior Human Factors Engineer
    Intuitive Apr 2022 - Present
    California, 94086, Us
  • Bose Corporation
    User Research Engagement Lead
    Bose Corporation Nov 2021 - Mar 2022
    Framingham, Massachusetts, Us
    • Represented User Research team within Bose’s Health organization, collaborating closely with Health leaders to identify where user research and human factors testing can influence hearing aid strategy and design• Developed overall user research plan and execution for hearing aid and associate software application• Mentored junior user research teammates
  • Emergo By Ul
    Senior Human Factors Specialist
    Emergo By Ul Jan 2020 - Nov 2021
    Austin, Tx, Us
    • Led various human factors engineering activities for pharmaceutical and medical device companies: developed user needs, developed user profiles and use environment descriptions, performed known problems analyses, conducted task analyses, conducted use-related risk analyses,• Prepared and conducted remote and in-person human factors evaluations for devices ranging from combination products to complex medical device systems (i.e., surgical robotics, bedside monitoring) • Managed relationships with various pharmaceutical and medical device clients • Created standard operating procedures in compliance with ISO 13485:2016
  • Stryker
    Staff Usability Engineer
    Stryker May 2018 - Dec 2019
    Kalamazoo, Mi, Us
    • Developed human factors evaluation strategy and led usability activities for Mako robotic system• Mentored entry level human factors engineer in human factors engineering best practices • Developed user profiles and use environment descriptions to drive product requirements• Evaluated robotic clinical workflow by conducting Perception, Cognition, Action (PCA) analysis• Evaluated use-related risks for robotic software applications, identified risk controls, and developed additional product requirements to incorporate design related risk control measures back into product design• Planned and conducted human factors evaluations by recruiting representative users and conducting evaluations in a simulated use environment based on the user profile and use environment descriptions• Provided product re-design recommendations to Systems Engineering based on human factors evaluations• Developed and executed HF validation by evaluating high-risk hazard related use scenarios per IEC 62366:2016 and IEC 14971:2012• Represented robotics human factors engineering team in Stryker corporate human factors engineering meetings
  • Stryker
    Staff Design Assurance Engineer
    Stryker Mar 2018 - May 2018
    Kalamazoo, Mi, Us
    • Developed training materials and provided training to R&D and Systems Engineering on the human factors engineering process for medical devices• Collaborated with R&D in executing design control and risk management activities (Hazard Analysis, dFMECAs, AFMEAs and SRAs) across multiple projects
  • Stryker
    Senior Design Assurance Engineer
    Stryker Mar 2016 - Feb 2018
    Kalamazoo, Mi, Us
    • Served as design assurance engineer to R&D engineers to develop next generation surgical robotics system• Led requirements development strategy by collaborating with Systems Engineering and design teams to develop system / sub-system requirements• Led and documented risk management activities in risk management plan per ISO 14971• Evaluated system level safety risks via Hazard Analysis, Fault Tree Analysis, and FMEAs• Trained R&D Organization on medical device design controls and risk management activities• Attended AAMI’s human factors for medical devices training• Developed and launched human factors engineering process per IEC 62366 for Stryker robotics• Supported FDA and notified body audits of quality system as audit scribe and backroom coordinator assistant
  • Stryker
    Design Assurance Engineer
    Stryker Sep 2014 - Feb 2016
    Kalamazoo, Mi, Us
    • Responsible for evaluating safety risks of new surgical robotic software applications during product development• Reviewed system/sub-system requirements for new robotic total knee application• Reviewed system/subsystem design verification protocols/reports and design validation protocols/reports• Supported cadaveric design validation labs as note taker• Monitored quality of commercially available robotic systems and software applications via complaint handling and product field actions• Presented post-market surveillance data monthly to robotics senior leadership team
  • Livanova
    Clinical Engineer, Clinical Medical Affairs
    Livanova Jan 2013 - Sep 2014
    London, Gb
    • Responsible for evaluating usability and safety risk of neurostimulator systems during product development • Assisted with human factors engineering evaluations with end users and identification of use errors• Developed content for different product lines’ Instructions for Use and Quick Reference Cards• Collaborated with Marketing to perform market and usability research for new neurostimulators• Led neurostimulator training and implantation portions of site initiation visits for a domestic clinical trial• Supported cases to facilitate successful implantation during domestic and European clinical trials
  • Livanova
    Strategic Project Specialist
    Livanova Jul 2012 - Jan 2013
    London, Gb
    Led communications between an internal design team and outside vendor to create new surgeon training video
  • The University Of Iowa
    Materials Science Teaching Assistant
    The University Of Iowa Jan 2011 - May 2011
    Iowa City, Iowa, Us
    • Monitored students performing laboratory exercises pertaining to determining material properties• Assisted in grading laboratory reports
  • The University Of Iowa
    Research Assistant At Reinhardt Biomedical Imaging Lab
    The University Of Iowa Feb 2009 - May 2011
    Iowa City, Iowa, Us
    Assessed accuracy of image registration to track lung tissue deformation during respiration in animals, lung cancer patients, and COPD patients
  • The University Of Iowa
    Calculus I Tutor - Trio Student Support Services
    The University Of Iowa Aug 2008 - May 2010
    Iowa City, Iowa, Us
    • Met with students twice a week to cover important concepts and answer questions• Provided students with studying tips and test taking strategies

Divya Maxwell Skills

Medical Devices Biomedical Engineering Fda Product Development Validation R&d Clinical Research Clinical Trials Iso 13485 Laboratory Training Biomaterials Matlab Usability Engineering Biotechnology U.s. Food And Drug Administration Quality System Design Control Cross Functional Team Leadership

Divya Maxwell Education Details

  • The Johns Hopkins University
    The Johns Hopkins University
    Bioengineering Innovation And Design
  • University Of Iowa
    University Of Iowa
    Biomedical Engineering

Frequently Asked Questions about Divya Maxwell

What company does Divya Maxwell work for?

Divya Maxwell works for Intuitive

What is Divya Maxwell's role at the current company?

Divya Maxwell's current role is Senior Human Factors Engineer at Intuitive.

What is Divya Maxwell's email address?

Divya Maxwell's email address is di****@****oup.com

What schools did Divya Maxwell attend?

Divya Maxwell attended The Johns Hopkins University, University Of Iowa.

What skills is Divya Maxwell known for?

Divya Maxwell has skills like Medical Devices, Biomedical Engineering, Fda, Product Development, Validation, R&d, Clinical Research, Clinical Trials, Iso 13485, Laboratory, Training, Biomaterials.

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