<b>Duties</b><br /><br /><b>Summary</b><br /><br />This Direct-Hire position is located at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of the Center Director (OCD) located in Silver Spring, Maryland.<br /><br />Learn more about this agency <br /><br /><b>Responsibilities</b><br /><br /><ul> <li>Provide engineering analytical consulting on a variety of regulatory and quality management issues and matters.</li> <li>Serve as the team/project leader for process improvement teams on quality assurance issues.</li> <li>Evaluate the impact of procedures on scientific and regulatory policies, overall activities, and priorities of the quality management program.</li> <li>Use continuous process improvement (CPI) as a tool or systemic approach to improve the efficiency of the Center products and services.</li> <li>Develop and implement policies, practices, and procedures to strengthen a department's core process and quality management initiatives.</li> </ul> <br /><br /><b>Travel Required</b><br /><br />Occasional travel – You may be expected to travel for this position.<br /><br />Supervisory status <br /> No <br /><br />Promotion Potential <br /> 14 <br /><br /></li> <b>Requirements</b><br /><br /><b>Conditions of Employment</b><br /><br /><ul> <li>This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).</li> <li>Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.</li> <li>Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.</li> <li>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.</li> <li>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.</li> <li>Research Positions may require evaluation of the scientific contributions, recognition, and professional standing of the researcher, and may be subject to peer review. A writing sample or publication portfolio may also be required.</li> <li>If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.</li> <li>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. Your application may be shown to multiple hiring offices.</li> <li>You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.</li> <li>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.</li> </ul> <br /><br /><b>Qualifications</b><br /><br /><strong>In order to qualify for the General Engineer, GS-0801-14, applicants must meet both the Basic Requirement AND Specialized Experience as follows: </strong><br /><br /><strong> BASIC QUALIFICATIONS: <br /> In order be eligible for the position of General Engineer,</strong> (GS-0801-14) <strong>, you must meet the following requirements:</strong><br /><br />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.<br /><br /><strong>OR</strong><br /><br />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: <li>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.</li> <li>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.</li> <li>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.</li> <li>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.)</li> <li>5. Successfully passed the Fundamentals of Engineering (FE) 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. Note: You must submit documentation of having passed the examination.</li> <li>6. Currently registered as an Engineer Intern (EI), Engineer in Training (EIT), or licensed as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. This registration must have been obtained by written test OR be in general engineering or a directly related engineering field and was gained by State grandfather or eminence provisions. NOTE: You must submit copies of your current registration.</li> <br /><strong>In addition to meeting the Basic Requirement stated above, applicants must possess the following experience: </strong>Have one year of specialized experience, equivalent to the next lower grade of GS-13 level or equivalent band level of responsibility in the Federal service: Review scientific and technical procedures, methodologies, inspections, and investigations in areas that require extensive interpretation. Interpret and implement quality management system policies, processes and procedures. Interpret and apply medical product specifications, technical data, regulations, policy statements and other guideline materials.<br /><br /><b>NOTE:</b> 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, https: my.usajobs.gov/Account/Login , select the <b>Application Status </b>link and then select the M<b>ore Information </b>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.<br /><br /><b>To return to an incomplete application</b>, log into your USAJOBS account and click <b>Update Application </b>in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.<br /><br /><strong>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.</strong><br /><br /><strong> All qualification requirements must be met by 11:59 pm (Eastern Time) on 06/01/2019 . </strong> <strong>If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.</strong> <br /><br /><b>Education</b><br /><br /><strong>Foreign Education</strong> <br /> 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.<br /><br /><strong>For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .</strong> <br /><br /><b>Additional information</b><br /><br /><strong>Additional Conditions of Employment: </strong> <ul> <li><strong>Pre-employment physical required:</strong> No</li> <li><strong>Drug testing required:</strong> No</li> <li><strong>License required:</strong> No</li> <li><strong>Mobility agreement required:</strong> No</li> <li><strong>Immunization required:</strong> No</li> <li><strong>Bargaining Unit Position:</strong> Yes, 3591</li> </ul> <b>Additional Information:</b> <ul> <li><strong>If you are serving, or have served in the last 5 years (from 06/01/2019) 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.</strong> 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. See Political Appointee FAQ – OPM for more… </li> <li><strong>Direct-Hire Authority</strong>: On October 11th, 2018, the Office of Personnel Management (OPM) issued a special government-wide Direct Hire Authority (DHA) for Scientific, Technical, Engineering, and Mathematics (STEM), and cyber security-related positions nationwide. This position is open to all U.S. Citizens and all qualified candidates will be referred for consideration. The hiring manager may select from any of these qualified candidates without regard to veteran's preference. Learn more about Direct-Hire on OPM's website… </li> <li><strong>Reasonable Accommodation: </strong>This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center Help Desk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestionsfda.hhs.gov . The decision on granting reasonable accommodation will be made on a case-by-case basis. See the Reasonable Accommodation Policy for more information… </li> <li><strong>Equal Employment Opportunity: </strong>The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor See the EEO Policy for more information… </li> </ul> <br /><br /><b>How You Will Be Evaluated</b><br /><br />You will be evaluated for this job based on how well you meet the qualifications above.<br /><br />Once the job opportunity announcement closes (at 11:59 pm ET on 06/01/2019), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.<br /><br /><strong>Because this vacancy will be filled through OPM's Direct Hire Authority , Veterans Preference and traditional rating and ranking of applicants do NOT apply to positions filled under this announcement. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority. All qualified candidates will be referred for consideration; the hiring office may conduct interviews at their discretion.<br /><br />Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.<br /><br />1. General Engineering<br /> 2. Project Management<br /> 3. Reasoning<br /> 4. Planning and Evaluating<br /> 5. Strategic Thinking</strong><br /><br />Please follow all instructions carefully. Errors or omissions may affect your eligibility. <br /><br /><b>Background checks and security clearance</b><br /><br />Security clearance <br /> Other <br /><br />Drug test required <br /> No <br /><br /></li> <b>Required Documents</b><br /><br /><strong><ul><li>Resume</li><li>Transcript</li></ul></strong><br /> A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete. <br /><br /><ul><li>Cover Letter</li><li>DD-214</li><li>OF-306</li><li>Professional License or Certificate, Performance Appraisals, Awards, etc.</li><li>VA Letter or other Veteran-supporting documents</li><li>Resume</li><li>SF-15</li><li>SF-50</li><li>Transcript</li></ul> <br /> These documents may be required for some applicants . Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. <strong>RESUME REQUIREMENTS:</strong> <br /> The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this <strong> Resume Writing Tutorial </strong>video on the USAJOBS YouTube channel , or read through a helpful <strong> Resume Writing FAQ </strong> on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.<br /> <strong>At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.</strong> <br /><br /><strong>Learn more about supporting documents and documentation requirements on USAJOBS:</strong> <ul> <li> How to Understand the Required Documents Section </li> <li> What Types of Documents May I Need? </li> <li> How to Manage Your Documents on USAJOBS </li> </ul> <br /><br /><b>If you are relying on your education to meet qualification requirements:</b><br /><br />Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education . <br /><br />Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.