Danny Lee
About Danny Lee
Danny Lee is an Associate Software Validation Engineer with extensive experience in validating medical imaging applications and expertise in FDA regulations. He has worked in various engineering roles across multiple companies, including ThermaCELL and Parexel, and has been with CALYX since 2015.
Work at CALYX
Currently, Danny Lee holds the position of Associate Software Validation Engineer at CALYX, where he has been employed since 2015. In this role, he focuses on validating software applications, particularly in the medical imaging sector. His responsibilities include conducting peer reviews of validation documentation and collaborating with developers and project teams throughout the Software Development Life Cycle. This collaboration ensures that validation processes meet the necessary standards and requirements.
Education and Expertise
Danny Lee earned a Bachelor of Science degree in Computer Engineering from the Rochester Institute of Technology, completing his studies from 2006 to 2012. He possesses expertise in FDA regulation 21 CFR Part 11 and GxP principles, which are essential for compliance in software validation for medical applications. His specialization includes validating medical imaging applications using established criteria such as RECIST, irRECIST, mRECIST, Cheson, Lugano, and MSK.
Previous Work Experience
Before joining CALYX, Danny Lee accumulated diverse experience in various engineering roles. He worked as an Associate Software Validation Engineer at Parexel from 2015 to 2020. Prior to that, he held positions as a Project Engineer at AG Mednet Inc. and as a Returns/Engineering Technician at ThermaCELL. He also completed co-op positions as a Hardware Verification Engineer at PT and as a Software Engineer at Harris Corporation. His early career included an IT internship at Lesley University and a role as a Lifeguard for the City of Boston.
Technical Skills and Tools
Danny Lee is experienced in using defect and issue tracking tools such as BugZero and JIRA, which are integral to the software validation process. His technical skills enable him to conduct thorough peer reviews of validation documentation, requirements, and technical specifications. This attention to detail is crucial for maintaining high standards in software validation, particularly in the medical field.