Medical Technologist

Duties

If selected for this position, you will:

• Serve as a senior level molecular genetics, pathology, and cytology medical device review of scientific data to determine the safety and efficacy of medical devices;
• Review scientific data submitted in support of a variety of medical device submissions such as pre-market applications (PMAs), product develop protocols (PDPs), applications for investigational device exemptions (IDEs), premarket notification of intent to market a device, and reports, such as establishment inspection reports (EIRs), to determine if a regulatory decision on the safety and effectiveness of the device can be made;
• Review research protocols to evaluate molecular genetics, pathology, and cytology medical devices;
• Write and evaluate guidelines concerning the data required in submissions to the Agency for medical devices and their marketing;
• Serve as an expert witness in area of scientific specialty in court cases dealing with medical devices.

Qualifications

In order to qualify for a Medical Technologist, GS-0644-13 position, you must meet the following:

BASIC QUALIFICATIONS

A. Degree: Medical technology, chemistry, or biology that included or was supplemented by at least:

• 16 semester hours of biological science of which one course was in microbiology and one course was in immunology. (NOTE: If there is no mention of immunology or immunobiology in the course title, the requirement for a course in immunology may be met by any course that covers the following topic areas: (1) definition and relationships of antigens and antibodies; (2) host-antigen interactions; (3) bursal and thymic influences on lymphoid cells; and (4) humoral and cellular response mechanisms.) The remaining biology courses must have been in general biology, zoology, or any of the areas listed below under "Evaluation of Education and Experience;"
• 16 semester hours of chemistry of which one course was in organic or biochemistry. The remaining chemistry courses must have been in general chemistry, qualitative analysis, qualitative chemistry, quantitative chemistry, physical chemistry, analytical chemistry, or any of the areas listed below under "Evaluation of Education and Experience;" and
• 3 semester hours of college mathematics.

-OR-

B. A full 4-year course of study that included or was supplemented by at least 12 months in a college or hospital-based medical technology program or medical technology school approved by a recognized accrediting organization. The professional medical technology curriculum may have consisted of a 1-year post-baccalaureate certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor's in medical technology.

-OR-

C. A combination of (1) at least 35 semester hours of biological science, chemistry, and mathematics as described in paragraph A above and (2) additional appropriate education and/or experience totaling 4 years. This combination of education and experience must have provided knowledge of the theories, principles, and practices of medical technology equivalent to that provided by the full 4-year course of study described in A or B above. All science and mathematics courses must have been acceptable for credit toward meeting the requirements for a science major at an accredited college or university. Acceptable experience is responsible professional or technician experience in a hospital laboratory, health agency, industrial medical laboratory, or pharmaceutical house; or teaching, test development, or medical research program experience that provided an understanding of the methods and techniques applied in performing professional clinical laboratory work. Certification/licensure as a medical technologist (generalist) obtained through written examination by a nationally recognized credentialing agency or State licensing body is a good indication that the quality of experience is acceptable.

Evaluation of Education and Experience: The four major areas of clinical laboratory science are microbiology, clinical chemistry, hematology, and immunohematology (blood banking). Qualifying course work in these areas includes bacteriology, mycology, mycobacteriology, tissue culture, virology, parasitology, endocrinology, enzymology, toxicology, urinalysis, coagulation, hemostasis, cell morphology, immunology, serology, immunoserology, immuno-deficiency, hemolysis, histocompatibility, cyto-genetics, and similar disciplines or areas of laboratory practice. Related fields include physiology, anatomy, molecular biology, cell biology, embryology, pathology, genetics, pharmacology, histology, cytology, nuclear medicine, epidemiology, biostatistics, infection control, physics, statistics, and similar areas of science where the work is directly related to the position to be filled.

ADDITIONAL MINIMUM QUALIFICATION REQUIREMENTS

GS-13:

Specialized experience is experience that is typically in or related to the position and has equipped an applicant with the knowledge, skills, and abilities to successfully perform the duties of the position.

You must have one (1) year of specialized experience which is equivalent to at least the GS-12 grade level in the Federal service to include reviewing diagnostic tests of medical devices and radiation-emitting products and research protocols to evaluate medical device products, scientific projects, or research assignments.

Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.