Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rita Lin joined the U.S. Food and Drug Administration in 2017 as a Human Factors Reviewer in the Center for Devices and Radiological Health (CDRH).
At the FDA, her human factors reviews have focused on general hospital devices such as infusion pumps and pre-filled syringes, respiratory and anesthesia care, and digital health apps. She has been involved in providing edits to numerous standards, FDA guidance development, and teaching at external speaking events with HFES and AAMI, amongst others.
Rita previously worked in the orthopedic devices industry with experience in quality assurance (QA) and research & development (R&D). Her responsibilities included leading major design change projects, conducting empathic interviews, performing verification and validation testing and risk management, and implementing manufacturing process changes in Puerto Rico.
Rita earned her B.S. and M.S. in biomedical engineering and global health from Duke University.
 

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.