Divya Maxwell Email & Phone Number

California, 94086, Us

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

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

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

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

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

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

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

London, Gb

Led communications between an internal design team and outside vendor to create new surgeon training video

Iowa City, Iowa, Us

• Monitored students performing laboratory exercises pertaining to determining material properties• Assisted in grading laboratory reports

Iowa City, Iowa, Us

Assessed accuracy of image registration to track lung tissue deformation during respiration in animals, lung cancer patients, and COPD patients

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

Masters, Bioengineering Innovation And Design

Bachelors Of Science, Biomedical Engineering