David Henderson
Saint Joseph's University
From Swarthmore, PA
From Swarthmore, PA
Product Manager at DGH Technology
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David Henderson, a student at Saint Joseph's University, was inducted into Beta Gamma Sigma, the national business honor society
Over 130 graduate and undergraduate students from Saint Joseph's University's Haub School of Business were inducted into the national business honor society, Beta Gamma Sigma, during the Spring 201...
May, 02 2017 - Saint Joseph's University
Product Manager at DGH Technology
Medical Device Design & Development
Managed development of ultrasonic medical devices used to measure & image the eye.
Designed, programmed & tested novel algorithms to ensure accuracy of biometric
measurements.
Established relationships with doctors & key opinion leaders (domestically and
internationally). Used their input to establish product requirements & perform clinical testing.
Risk Analysis / Reliability Improvement
Performed FMEA and Risk Analysis activities for class II medical devices.
Established database system for tracking the failure modes of medical devices. Used the
results to identify risks & improve product reliability.
Regulatory
Maintained Quality System & performed all regulatory duties required to maintain ISO 13485
and FDA compliance.
Successfully led company through FDA inspections & annual ISO Audits.
Prepared Technical Files & 510k submissions for CE / FDA.
January 2009 - Present
