Michael Sweeney
Lynnfield,MA
Summary
Professional researcher with commitment to high standards and delivering results. Extensive experience in conducting and analyzing scientific studies, contributing to significant advancements in various fields. Known for fostering team collaboration and adapting to evolving research needs, bringing critical thinking and problem-solving skills to forefront.
Overview
23
23
years of professional experience
Work History
Senior Supervisory Regulatory Research Engineer
U.S. Food and Drug Administration/Winchester Engineering and Analytical Center
09.2020 - Current
- Responsible for11 highly specialized Engineering including several GS-14 Specialists
- Review analytical worksheets
- Conduct daily group meeting
- Manage leave, training requests, and purchase requests
- Provide training in inspection techniques and laboratory test methods
- Responsible for work planning
- Responsible for maintaining compliancy with WEAC’s quality system
- Review plans for new laboratory, to ensure the facility specifications meet analytical needs
- Lead WEACs transition to new building
- Hired and onboarded 4 engineers
Senior Regulatory Research Engineer
U.S. Food and Drug Administration/Winchester Engineering and Analytical Center
12.2009 - 09.2020
- Analysis of Medical Device Samples for compliance with regulations, performance standards, and manufacturer specifications
- Analysis of radiation emitting electronic products for leakage of unwanted non-ionizing radiation
- Research and development of new and better test methodologies for Medical Device Products analyzed by the laboratory
- Analysis resulting in recalls, Denial of entry of imported product into the United States, and Criminal charges brought on violators of FD&C Act
- Lead laboratories UV lamp testing program
- Foreign Inspection of Microwave Oven Manufacturers
Consumer Safety Officer
U.S. Food and Drug Administration/District Office
04.2002 - 12.2009
- Conduct Quality System Inspections of Medical Device Manufacturers
- Premarket Approval Inspections
- Consumer complaint investigations
- Write inspection reports
Education
Bachelor of Science - Biomedical Engineering
Worcester Polytechnic Institute
01.2002
Skills
- Monitoring and evaluation
- Presentation Skills
- Soft skills
- Radiation Safety Training
- Teamwork
- Problem-solving
- Time management
- Team leadership
- Effective communication
- Detail-oriented
- Quantitative and qualitative analysis
Publications
Use of Patient Simulators to Characterize the Repeatability and Reproducibility of Automated Oscillometric Blood Pressure Monitors” Blood Pressure Monitoring,2018.
Timeline
Senior Supervisory Regulatory Research Engineer
U.S. Food and Drug Administration/Winchester Engineering and Analytical Center
09.2020 - Current
Senior Regulatory Research Engineer
U.S. Food and Drug Administration/Winchester Engineering and Analytical Center
12.2009 - 09.2020
Consumer Safety Officer
U.S. Food and Drug Administration/District Office
04.2002 - 12.2009
Bachelor of Science - Biomedical Engineering
Worcester Polytechnic Institute
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