Interdisciplinary Engineer

DutiesThis position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), Office of Clinical Evidence and Analysis (OCEA), in Silver Spring, Maryland.OCEA provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.The Office provides policy and program support for clinical evidence and human subject protection - In addition to:regulatory oversight of medical device clinical investigations, good laboratory practice (GLP), and good clinical practice (GCP) issues in support of premarket review.OCEA also provides biostatistical and epidemiologic analyses, as well as support in the development of data infrastructure and expertise on clinical investigations and real-world evidence.As a Senior Scientist in OCEA, you will:Prepare evaluations and conduct research in all areas of medical device and radiation-emitting electronic products;Determine the adequacy of information submitted and the thoroughness of data contained in scientific protocols, findings of studies or medical device evaluations submitted to the Agency by the regulated industry;Collaborate and prepare comprehensive, concisely written reviews regarding scientific protocols, findings of studies or medical device evaluations.Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit for more info.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. QualificationsThe position of Interdisciplinary Engineer falls within the 0801/0830/0850/0858 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 03/02/2022.To Qualify for the Senior Scientist - Interdisciplinary Engineer, GS-801-830-850-858, GS-14, you must meet A or B of the one of the basic qualification listed below and the Specialized Experience: A. Degree: Engineering. To be acceptable, the program must: (1) lead to a bachelor's degree in a school of engineering with at least one program accredited by ABET; 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 B. 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 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. The adequacy of such background must be demonstrated by one of the following:

1. Professional registration or licensure -- Current registration as an Engineer Intern (EI), Engineer in Training (EIT)1, or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. Absent other means of qualifying under this standard, those applicants who achieved such registration by means other than written test (e.g., State grandfather or eminence provisions) are eligible only for positions that are within or closely related to the specialty field of their registration. For example, an applicant who attains registration through a State Board's eminence provision as a manufacturing engineer typically would be rated eligible only for manufacturing engineering positions.
2. Written Test -- Evidence of having successfully passed the Fundamentals of Engineering (FE)2 examination or any other written test required for professional registration by an engineering licensure board in the various States, the District of Columbia, Guam, and Puerto Rico.
3. Specified academic courses -- Successful completion of at least 60 semester hours of courses in the physical, mathematical, and engineering sciences and that included the courses specified in the basic requirements under paragraph A. The courses must be fully acceptable toward meeting the requirements of an engineering program as described in paragraph A.
4. Related curriculum -- Successful completion of a curriculum leading to a bachelor's degree in an appropriate scientific field, e.g., engineering technology, physics, chemistry, architecture, computer science, mathematics, hydrology, or geology, may be accepted in lieu of a bachelor's degree in engineering, provided the applicant has had at least 1 year of professional engineering experience acquired under professional engineering supervision and guidance. Ordinarily there should be either an established plan of intensive training to develop professional engineering competence, or several years of prior professional engineering-type experience, e.g., in interdisciplinary positions. (The above examples of related curricula are not all-inclusive.)AND

Specialized Experience:You must have at least one full year (52 weeks) of specialized experience equivalent to at least the GS-13 level or equivalent band of responsibility: Reviewing quality, clinical, scientific, and other data in support of a variety of medical device and radiological health programs; Advising on the adequacy of research study documentation, protocols, methodologies, data analyses, medical device evaluation and/or interpretations of results; and Developing rulemaking, guidance documents, and other policies in response to specific requests from industry.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.PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, , select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.You must submit supporting documentation to verify your eligibility to apply for this vacancy. For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...EducationEDUCATION:TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. 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, see the Foreign Education section below for additional requirements. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.See the Application Manager Documentation for tips on submitting your paper-based documents.FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE)Credential evaluations are not free, and applicants are responsible for the cost of the selected service.For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education EvaluationAdditional informationADDITIONAL CONDITIONS OF EMPLOYMENT: Due to COVID-19, the agency is currently in an expanded telework posture. If selected, you may be expected to temporarily telework, even if your home is located outside the local commuting area. Once employees are permitted to return to the office, you will be expected to report to the duty station listed on this announcement within 45 days. At that time, you may be eligible to request to continue to telework one or more days a pay period depending upon the terms of the agency's telework policy.NOTE: To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Safer Federal Workforce Task Force guidance on other Federal agency safety protocols based on vaccination status-including guidance on protocols related to masking, distancing, travel, testing, and quarantine-remains in effectWe may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.Pre-employment physical required: NODrug testing required: NOLicense required: NOMobility agreement required: NOImmunization required: NOBargaining Unit Position: YES, 3591If you are serving, or have served in the last 5 years (from 03/02/2022) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: .All requirements must be met by the closing date of this announcement (03/02/2022); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process. Additional selections may be made within the same geographical area FDA-wide.Help Help A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits. Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.