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Employment Opportunity for Biomedical/Mechanical/ Electrical Engineers The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is looking for engineers to serve as reviewers of premarket submissions in its Division of Cardiovascular Devices located at FDA headquarters in Silver Spring, MD. Job Description: The position is for mechanical, biomedical or electrical engineers. The incumbent will: 1. Lead teams of engineers, scientists, and clinicians in the premarket scientific review of medical devices in the Division of Cardiovascular Devices at FDA; 2. Conduct engineering reviews of marketing applications for cardiovascular medical devices, such as ventricular assist devices, heart valves, stents, angioplasty catheters, endovascular grafts, occluders, pacemakers, ablation catheters, automated external defibrillators, cardiac monitors, mapping systems and emerging cardiovascular therapies and technologies; 3. Engage in all aspects of the total product life cycle: medical device design, bench tests, preclinical animal studies, clinical trial design, premarket review, manufacturing and postmarket surveillance. Preferred coursework, experience, or research areas: electronics, instrumentation, physiology, cardiac electrophysiology, biostatistics, reliability engineering, material science, tissue engineering, mechanical design. Desired skills: Strong engineering and critical thinking skills, excellent written and oral communication skills, and team and time management skills are all essential for this position. Knowledge of FDA regulations is desired, but not necessary. Benefits: Stimulating, high-impact work environment at the cutting edge of cardiovascular medical device technologies; flexible work hours and partial telecommuting arrangements available. FDA reviewers receive full benefits as salaried federal employees. Level of Education Sought: BS, MS or higher. Citizenship: Should be a United States citizen or permanent resident of the United States Experience Sought: Flexible, although experience in the medical device industry is preferred. If you are interested in an informational interview, please email a CV/resume and cover letter ‘RESUME FOR CONSIDERATION: [Your Name]’ to: [email protected] FDA IS AN EQUAL OPPORTUNITY EMPLOYER AND HAS A SMOKE FREE ENVIRONMENT. TO QUALIFY FOR EMPLOYMENT, ALL APPLICANTS MUST MEET ALL CIVIL SERVICE OR COMMISSIONED CORPS REQUIREMENTS INCLUDING U.S. CITIZENSHIP.