General Engineer

Summary

This Direct-Hire position is in the Food and Drug Administration, located in the Center for Devices and Radiological Health. CDRH assures that patients and providers have access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical devices innovation by advancing regulatory science, providing industry with consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Duties

• This position is located in the Center for Devices and Radiological Health (CDRH), Office of Science and Scientific Laboratories (OSEL) in Silver Spring, Maryland. OSEL supports the CDRH mission of protecting and promoting public health.
• As a General Engineer in OSEL, you will be responsible for:
• Providing scientific information and consultation to industry, academic, and private laboratory scientists conducting research on the safety and effectiveness of materials used in the manufacture of medical devices.
• Preparing and presenting briefings to higher-level management and recommending program enhancements.
• Reviewing technical data submitted in support of the device submissions with respect to accuracy, precision, and reliability and making a judgment on whether the supporting data provided are sufficient to substantiate labeled claims.

Requirements

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• 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.
• 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.
• 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.
• 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.

Qualifications

The position of General Engineer falls under the 0801 occupational series. To qualify for this position at grade GS-12, you must meet all requirements by 11:59 pm EST on 10/18/2024.

Basic Requirements: You must meet the basic education requirements for this position.

1. 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.
2. 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), or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico.
2. Written Test -- Evidence of having 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.
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.
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.

AND

Minimum Qualifications:

Specialized Experience: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

For the GS-12 level: You must have one full year (52 weeks) of specialized experience equivalent to at least the GS-11 or equivalent band level of responsibilities in the Federal service, which includes providing technical written and oral guidance on medical device products; analyzing and interpreting scientific documents, data sets, technical information, and/or opinions related to medical device products; evaluating guidelines based on scientific data for processes or products related to medical devices and/or medical products.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 10/18/2024. 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.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy.

Required Documents

Resume: At a minimum, your resume should list the position title, employer name, 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.

Transcripts and Professional Licensure: If the position has an education or licensure requirement or you are qualifying based on education, unofficial transcripts or a list of courses and a copy of your professional license must be provided.

If you are relying on your education to meet qualification requirements:

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.

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.