Gregory Meyer Email & Phone Number

Canton, Ga, Us

Alpharetta, Georgia, United States

Develop and Implement best in class prototyping capabilities for efficient development of innovative medical devices.

United States

-Develop, plan, communicate and deploy project schedules. Responsible to meet project phase deliverables and milestones for MDR submissions.-Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals for successful technical file submission to notified body.-Support the development of harmonized business processes and procedures for execution and compliance with EU MDR-Communicate effectively with program leadership to ensure clear expectations, demonstrate progress and identify issues. Provide progress updates and regular reporting to business and functions leadership-Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resourcesCollaborate with project team, business units, and workstream/shared services leads, as well as functional leaders from regulatory, quality and clinical functions to finance, R&D and operations to ensure efficient execution of a shared strategy for MDR.

Suwanee, Georgia, United States

•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.

Greater Atlanta Area

Product Development Engineer and project leader for Ecolab focused on OEM surgical draping products for the divisions largest customer.-Managed cross-functional projects as technical lead and project manager-Developed and maintained product specifications in a controlled document environment.-Completed all development and project work in accordance with GMP and all relevant compliance standards.-Supported production both remotely and on-site at Ecolab facilities to ensure we did not face downtime or back-order situations.-Chosen to work as a dedicated resource for Ecolab Healthcare's largest customer.

Greater Atlanta Area

I worked on the development, production and testing of the LuViva Advanced Cervical Scan device in the role of Research Engineer.-I was responsible for the design and execution of various electrical safety bench top experiments-Authored reports and procedures-Designed and implemented a RoHS database for the LuViva cervical cancer device-Designed and built test fixtures including a leakage current box for IEC 60601-Assisted in electrical and safey compliance testing-Worked on RMA device upgrades for LuViva cervical cancer device

Greater Atlanta Area

Worked as a Research Scientist on an NIH Phase II grant with the goal of creating a microfluidic platform for automatic and continuous harvesting of interstitial fluid for cortisol measurement.-Assisted on the completion of a NIH Phase II grant-Authored Grant Applications to the NIH, DOD, NSF, and CDMRP-Contributed to the design and development of a microfluidic medical device platform-Designed and executed bench top experiments to prototype and test the microfluidic platform-Organized and completed 4 24 hour clinical studies with paid subjects-Extracted and labeled all samples collected during the clinical studies-Analyzed data for inclusion in the NIH final report-

Greater Atlanta Area

-Created work instructions and operating procedures for manufacture of medical devices-Assisted in performing Process Failure Mode Effects Analysis and product line validations-Created documentation and forms to assist with audits determining FDA compliance

· Installed software programs and performed troubleshooting tasks.· Repaired and installed computer hardware· Managed student computer labs· Provided training to support staff. Assisted with Web page updates.

Bachelor Of Science, Biomedical Engineering

Activities and Societies: Biomedical Engineering Society, Sailing Club, Order of the EngineerAt Georgia Tech I gained a base knowledge.

Education record