Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Lean & Compliant Medical Device Development
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About
Biomedical engineer with over 20 years of experience in medical device development over a wide range of technologies, from surgical robotics to x-ray imaging systems to catheters to drug inhaler devices. Broad experience implementing and managing design controls, from work at small startups to global corporations.
Experienced in the following areas:
· Incorporating lean and agile methods into medical device development
· Implementing requirements management tools for streamlined compliance
· Design verification and validation testing (V&V) for software and hardware
· Writing and managing product requirements, software requirements, hardware requirements
· Risk management for new product...
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Tags
medical devices
design controls
lean product development
fda
agile software development
risk management
quality system
a3 method
compliance
regulatory
iso 13485
iso 14971
agile
iot
cybersecurity
cost of change
software testing
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