Rohini Deb

Senior Human Factors Engineer at Healthcare Optics Research Laboratory, Canon U.S.A.
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Contact Information
us****@****om
(386) 825-5501
Location
Boston, Massachusetts, United States, US
Languages
  • English -
  • Spanish -
  • Bengali -

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Human Factors Engineer
      • Apr 2021 - Present

    • Co-Founder of Canon USA Women in Leadership Levels (WiLL) Cambridge Chapter
      • Aug 2019 - Present

      I founded Canon HORL WiLL Chapter in Cambridge with the support of three other women to create an opportunity for women in our workplace to be encouraged to lead, provide women with opportunities for higher skill development, and continuously educate our membership about topics that support a diverse workplace. Our pillars of focus are Networking, Professional Development, Mentoring, and Community Outreach. I additionally serve as Community Outreach Chair and work with Girls Inc. of Lynn/Boston in Massachusetts to create programing, employing the talents of our HORL WiLL membership, to encourage STEM learning and careers to girls of ages 6-18 from underserved communities in the Boston area.

    • Human Factors Engineer
      • Jun 2019 - Apr 2021

      Worked with clinicians to help identify pain points in cardiovascular imaging workflows to design and validate safe and effective products that provide real-world solutions. - GUI Design- User Interface Requirements- Use FMEA/ Task Analysis creation- Formative and Summative Testing with clinicians, nurses, technicians, and service providers- Provide input to Marketing strategy- Validation Planning- IEC 62366 compliance- Preference/Generative Testing- PCA Tool Analysis- IFU design- HE75 proficiency

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Design Quality Assurance Engineer II
      • Feb 2016 - Jun 2019

      Working in New Product Development in the Endoscopy Division in Marlborough, MA. Lead DQA on cross functional teams for projects involving tissue resection, endoscopic visualization, surgical visualization devices, and balloon ablation catheters.- Lead Risk management and usability efforts across all projects- Worked with 100+ physicians/surgeons worldwide to conduct design validation studies and obtain user feedback- Lead software upgrade distribution scheme for product currently in the field- now used by other divisions- Collaborated with global distribution teams to initiate manufacturing cut- over for next gen products- Lead an ex-vivo model validation efforts resulting in a >$200K cost savings- Developed reliability and practical equivalence testing experiments to assess next gen product performance- Collaborated on 60601 testing efforts and documentation - Established quality plans for accepting product at risk with robust inspection methods

    • Supplier Engineer II- Capital Equipment
      • Feb 2015 - Feb 2016

      Temporary offsite assignment: Cambridge, MAElectro-Physiology- Capital EquipmentCollaborate cross functionally to execute procurement strategy, quality compliance, and design integration for second generation catheter mapping system.-Created virtual material inspection and receipt system in Cambridge -Implemented quality control programs at Cambridge site to aid with product compliance-Fostered the relationship between R&D and vendors to create a collaborative, idea-sharing environment to better enhance the quality of material designed-Operated in three quality systems to move material and integrate quality controls for new product-Creating the baseline for Design Verification of new products-Created Sampling plans based on Risk for new product testing -Implemented process capability inspections at suppliers based on design for PCBAs, FPCs, cables, metals, injection molded plastics, packaging and labeling.Implemented and executed the following activities:-Component Material Assessment Process-RoHS compliance-ISO 13485 Compliance-Review of IQ, OQ, and PQ protocols-First Article Inspection-Acceptance Activities -SAP/Inspection Procedures implementation for new products-Materials property testing evaluation-Non-conformance processes (NCEP) -Corrective Action processes-DCAFs-Supplier Change Requests-Field Action Escalations-Product Rework-Product Disposition and Transfer-Engineering Studies

    • Supplier Engineer I
      • Feb 2014 - Feb 2015

      Electro-Physiology- Single Use Devices:Perform quality integration for a catheter mapping system.Collaborate cross functionally with Quality, R&D, and Purchasing to qualify new suppliers to BSC's quality program.Implement and execute the following activities:-Statistical Analysis/Sampling plan creation-Component Material Assessment Process-RoHS compliance-ISO 13485 Compliance-Review of IQ, OQ, and PQ protocols-First Article Inspection-Acceptance Activities -SAP/Inspection Procedures implementation for new products-Materials property testing evaluation-Non-conformance processes (NCEP) -Corrective Action processes-DCAFs-Supplier Change Requests-Field Action Escalations-Product Rework-Product Disposition and Transfer-Engineering Studies

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Process Validation Engineer
      • Aug 2013 - Feb 2014

      Create and process IQ, PQ, and OQ’s and other Process Validation Documents (CSV, PVP, PVS, TMV's) for an Oxygen delivering wound dressing product. In addition, conduct design of experiments for the dressing.Conducted Environmental Validation for Controlled Manufacturing Area to ISO-8 Standard. Create and process IQ, PQ, and OQ’s and other Process Validation Documents (CSV, PVP, PVS, TMV's) for an Oxygen delivering wound dressing product. In addition, conduct design of experiments for the dressing.Conducted Environmental Validation for Controlled Manufacturing Area to ISO-8 Standard.

    • United States
    • Higher Education
    • 700 & Above Employee
    • Researcher
      • Sep 2012 - Jun 2013

      Created a mobile application for the iPhone that acts as a endoscopic device by conducting acoustic analysis on vocal folds. Created a mobile application for the iPhone that acts as a endoscopic device by conducting acoustic analysis on vocal folds.

    • United States
    • Higher Education
    • 700 & Above Employee
    • Clinical Consultant for CT Scan Machines
      • Jun 2012 - Sep 2012

      Created a program to calculate and record to the Electronic Medical Record (EMR), the radiation delivered to patients who undergo CT scans. Created a program to calculate and record to the Electronic Medical Record (EMR), the radiation delivered to patients who undergo CT scans.

    • United States
    • Hospitals and Health Care
    • Pediatric Cardiology Research Intern
      • May 2011 - Dec 2011

      Conducted research on effectiveness of 3D imaging versus 2D imaging in the analysis of cross circulation imaging on pig hearts. Pending publication. Abstract presented at the American College of Cardiology Conference in Houston, Texas in November 2013. Conducted research on effectiveness of 3D imaging versus 2D imaging in the analysis of cross circulation imaging on pig hearts. Pending publication. Abstract presented at the American College of Cardiology Conference in Houston, Texas in November 2013.

    • Pediatric Cardiology Laboratory Intern
      • 2007 - 2008

      Conducted research and presented and published a paper at the American Conference of Cardiology in Orlando, FL in 2009 on the strain rates of different imaging tools on the heart Conducted research and presented and published a paper at the American Conference of Cardiology in Orlando, FL in 2009 on the strain rates of different imaging tools on the heart

Education

  • Questrom School of Business, Boston University
    Master of Business Administration - MBA, Health Sector Management
    2020 - 2023
  • HBX | Harvard Business School
    CORe Credential of Readiness, Pass with Honors
    2017 - 2018
  • Santa Clara University
    Bachelor's degree, Biomedical/Medical Engineering
    2009 - 2013

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