For the GS-858-14 Biomedical Engineer position you must:
Possess at least one year of specialized experience equivalent to at least the GS-13 grade level in the Federal service. Examples include significant experience with the following: applying advanced engineering theories, principles, concepts, standards, and methods to provide expert advice to senior colleagues and/or agency officials regarding medical device issues. Work with the application of good clinical practices, human subject protections, clinical research, and recent developments allowing to review and provide recommendations to issues and questions related to the regulated industry and medical devices. Work that allowed collaborative working relationships with others at different levels within the organization. Experience presenting findings and recommendations in scientific terms, both verbally and in writing, including identifying and clearly presenting problems, proposals, and making recommendations, providing expert guidance to management and/or other staff at different levels within the organization. Experience working as an expert with scientific properties, analysis, behavior, and the impact of these properties as it relates to diagnostic tests and safety and effectiveness of medical devices. Experience with work involving the Federal Food, Drug, and Cosmetic Act as it relates to the regulation of medical devices.
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.
In addition to possess the required specialized experience, you must also meet the degree requirement listed below:
Degree: You must have successfully completed a full 4 year course of study, bachelor's or higher degree in professional engineering. To be acceptable, the curriculum must: (1) be in a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics (b) strength of materials (stress-strain relationships) (c) fluid mechanics, hydraulics (d) thermodynamics (e) electrical fields and circuits (f) nature and properties of materials (relating particle and aggregate structure to properties) and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics OR a combination of education and experience - college level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying professional engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering.
Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.
Conditions of Employment:
1. Additional Security and Background Requirements: May be referred depending on the position being filled. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. All qualification requirements must be met by the closing date of the announcement.
3. Financial disclosure statement may be required.
4. Travel, transportation, and relocation expenses will be paid: No
5. Bargaining Unit Position: No
6. Drug Screening Required: No
7. Recruitment Bonus may be authorized: No
8. Research position: No
9. Supervisory position: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Your qualifications will be evaluated and rated on the following competencies (Knowledge, Skills, Abilities (KSAs') and other characteristics): Please note that you do not need to address the KSAs' separately or in narrative format. KSAs' will be evaluated against your responses to te online questionnaire.
- Knowledge of safety signal management related to the postmarket medical device arena.
- Skill in communication and collaborative consultation with others.
- Ability to interpret and apply rules, regulations, and policies related to postmarket devices.