Deputy Office Director (Supervisory Biomedical Engineer)

This position is filled under a streamlined hiring authority (21 U.S. Code § 379d-3a) and offers a career or career-conditional appointment with pay determined by the Title 21 Pay Table 1, Band F.

Responsibilities

• Provide scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation.
• Serve as technical authority in clinical evidence evaluation, regulatory science, or engineering.
• Oversee and direct comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness.

Requirements

To qualify for the Deputy Office Director (Supervisory Biomedical Engineer) position (0858 occupational series), you must meet the following requirements by 11:59 PM EST on 08/24/2026:

Basic Qualification Requirements

• A. Degree: Engineering from a program that either:
  1. Leads to a bachelor’s degree in a school of engineering with at least one ABET-accredited program; or
  2. Includes differential and integral calculus and advanced courses (beyond first-year physics and chemistry) in five of these seven areas:
     • Statics, dynamics;
     • Strength of materials (stress-strain relationships);
     • Fluid mechanics, hydraulics;
     • Thermodynamics;
     • Electrical fields and circuits;
     • Nature and properties of materials (relating particle and aggregate structure to properties); or
     • Any comparable area of fundamental engineering science or physics (e.g., optics, heat transfer, soil mechanics, electronics).
• OR B. Combination of education and experience: College-level education, training, or technical experience demonstrating:
  1. A thorough knowledge of physical and mathematical sciences underlying engineering; and
  2. A strong theoretical and practical understanding of engineering sciences and techniques, applicable to a branch of engineering.

  This 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 U.S. state, territory, or district. If registration was achieved without a written test (e.g., via grandfather/eminence provisions), eligibility is limited to positions closely related to the specialty field of registration.
  2. Written test: Successful completion of the Fundamentals of Engineering (FE) examination or another written test required for professional registration by an engineering licensure board.
  3. Specified academic courses: At least 60 semester hours in physical, mathematical, and engineering sciences, including the courses specified in the basic requirements under paragraph A, fully acceptable toward an engineering degree.
  4. Related curriculum: A bachelor’s degree in an appropriate scientific field (e.g., engineering technology, physics, chemistry, architecture, computer science, mathematics, hydrology, geology) may substitute for an engineering degree, provided the applicant has at least one year of professional engineering experience under supervision. Typically, this requires either an established training plan or prior professional engineering experience.

Experience Requirements

In addition to the basic requirements, applicants must meet one of the following minimum experience criteria:

• Bachelor’s degree: 7 years of comparable experience in scientific and technical leadership for clinical evidence and analysis programs supporting medical device regulation.
• Master’s degree: 6 years of comparable experience in scientific and technical leadership for clinical evidence and analysis programs supporting medical device regulation.
• Doctorate/PhD and/or J.D. degree: 4 years of comparable experience in scientific and technical leadership for clinical evidence and analysis programs supporting medical device regulation.
• MD, DO, DDS, DPM, or DVM degree: 4 years of comparable experience in scientific and technical leadership for clinical evidence and analysis programs supporting medical device regulation.
• No advanced degree: 11 years of comparable experience in scientific and technical leadership for clinical evidence and analysis programs supporting medical device regulation.

All applicants must submit relevant transcripts demonstrating the required education.

About the Organization

The position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ).

CDRH protects and promotes public health by ensuring timely access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The center provides science-based information to consumers, patients, caregivers, and providers, while facilitating medical device innovation through predictable, consistent, and transparent regulatory pathways.