| Biomedical Engineer - FDA Cardiac Electrophysiology Devices Reviewer Position |
The position is for biomedical engineering candidates with a focus on electrical engineering, cardiac electrophysiology devices, and associated clinical studies in the Office of Device Evaluation’s Division of Cardiovascular Devices at FDA.
The candidate will be responsible for:
- Leading premarket scientific reviews in the Division of Cardiovascular Devices with teams of clinicians, engineers and interdisciplinary scientists and working closely with medical device manufacturers, clinical investigators, regulatory affairs managers and industry consultants; and
- Conducting technical reviews for marketing applications for new and modified devices such as pacemakers, defibrillators, ablation catheters, mapping catheters, imaging catheters, robotic systems, cardiac monitors, diagnostics devices, components and associated accessories; and
- Engaging in all aspects of the total product life cycle: medical device design, bench tests, preclinical animal studies, clinical trial design, premarket review, manufacturing and post-market surveillance.
Desired Skills: To perform this job, the ideal candidate would have education, experience, and interest in some of the following areas: cardiovascular medical devices (pacemakers, defibrillators, cardiac ablation/mapping technologies, cardiac diagnostic devices, and imaging catheters), electrical engineering, biomedical engineering, software engineering and validation, electrical components, EMI/EMC, device interoperability, device manufacturing, cardiac electrophysiology, clinical study design and evaluation, and FDA regulations.
The candidate should have excellent oral and written communication skills and be able to summarize complex technical issues in concise reports. With a diversity of assignments, the candidate must be capable of working independently, as part of a diverse technical review team, and as the leader of a review team. Candidates must have excellent organizational and multi-tasking skills and be able to schedule their efforts to meet demanding regulatory deadlines for their assignments.
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.
Location: The position is located at the FDA headquarters in Silver Spring, Maryland in the Washington D.C. Metro Area.
Application: Please submit a CV/Resume and cover letter to Mark.Fellman@fda.hhs.gov. Please note that due to the large number of expected applicants, only qualified candidates will be contacted for possible screening interviews.
About the FDA CDRH Mission:
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Career Opportunity: The FDA is headquartered at the 130-acre White Oak campus in Silver Spring, MD within the Washington DC Metro area. The FDA offers a stimulating and high-impact work environment with the opportunity to work at the cutting edge of cardiovascular medical innovations and technologies. The job opportunity provides candidates valuable training and experience in cardiovascular devices, clinical trial design, US Food and Drug Law, medical device regulations and critical exposure to the medical device industry. FDA reviewers are given the unique opportunity to work closely with both small start-up companies and Fortune 500 corporations on high profile projects with interdisciplinary teams of physicians, engineers and scientists to bring safe, effective and high quality medical innovations to patients and healthcare providers.
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 PERMANENT RESIDENCY AND/OR U.S. CITIZENSHIP.