- Manage the certificate scheme for approximately 27 medical device companies under the Medical Device Directive, Medical Device Regulations and ISO 13485. Including ensuring annual QMS audits meet regulatory requirements, reviewing and acting on product change notifications, vigilance/FSCA reviews, certificate renewals, etc- Review active medical device technical files for CE certification under the Medical Device Directive 93/42/EEC or Medical Device Regulations. Competencies include:… Show more - Manage the certificate scheme for approximately 27 medical device companies under the Medical Device Directive, Medical Device Regulations and ISO 13485. Including ensuring annual QMS audits meet regulatory requirements, reviewing and acting on product change notifications, vigilance/FSCA reviews, certificate renewals, etc- Review active medical device technical files for CE certification under the Medical Device Directive 93/42/EEC or Medical Device Regulations. Competencies include: Device for extracorpeal circulation, administration or removal of substances; Devices for stimulation or inhibition, Software only devices, Monitoring devices of vital and non-vital physiological parameters, medical devices which are also machinery, medical devices incorporating software. Competency for Unannounced Audits. - Certificate in Medical Devices Quality Management Systems ISO 13485:2016 (MD), Management Systems Auditing ISO 19011:2018 (AU), Leading Management Systems Audit Teams ISO 19011:2018 (TL) Show less

- Safety testing evaluation of medical devices to US, Canadian, and other International Standard versions of IEC 60601-1, Medical Electrical Equipment- Part 1: General requirements for Basic Safety and Essential Performance- Evaluate Risk Management Procedure and product specific assessments to ISO 14971 and IEC 60601-1- Evaluate PEMS (Programmable Electrical Medical Systems) to IEC 62304 in accordance with IEC 60601-1- Perform evaluations of particular and collateral standards for… Show more - Safety testing evaluation of medical devices to US, Canadian, and other International Standard versions of IEC 60601-1, Medical Electrical Equipment- Part 1: General requirements for Basic Safety and Essential Performance- Evaluate Risk Management Procedure and product specific assessments to ISO 14971 and IEC 60601-1- Evaluate PEMS (Programmable Electrical Medical Systems) to IEC 62304 in accordance with IEC 60601-1- Perform evaluations of particular and collateral standards for device specific applications. Examples include home healthcare, alarms, electrocardiographs, high frequency surgical equipment, ultrasonic medical diagnostic and monitoring equipment, and medical non-laser light sources. - Responsible for providing communication of project status between the client, management and sales staff throughout the evaluation and testing.- Work with sales staff as needed to provide quoting for new projects Show less

Assisted in development of an innovative Esophageal Cancer device, from creating and improving documentation (Risk management, software documentation, Product development documentation) to building prototypes and bench testing the alpha prototypes. Created and improved software documentation for the LuViva Cervical Diagnostic device. Also authored several verification documents and assisted with verification testing of the production units.

Worked with Dr. Wong and Dr. Pak and a team of students from Georgia Tech on an alternative tissue ligation clip to be used in prostatectomy surgery.Duties included:- Solidworks design of ligation clip- Research papers- Writing a 510(k)- Using 3-D rapid prototyping and waterjet to create working prototype

Worked on two projects at CATEA, the first being a student project on the Wii gaming system, and the second was a research study on pressure ulcers.Duties included calibration of pressure mapping equipment, documenting test procedures, observing patients in a clinical setting, and developing calibration protocols for new pressure sensors.