SHPE

Interdisciplinary Scientist (Cybersecurity Specialist)

Spotlight Preferred
US Food & Drug Administration
Silver Spring, Maryland, United States
30+ days ago

Description

The position of Interdisciplinary Scientist may be filled by candidates from the following occupational series: Miscellaneous Administration and Program Series (0301), General Health Scientist/Epidemiologist (0601), General Engineer (0801), General Mathematics and Statistics (1501), Mathematical Statistician (1529), and Computer Scientist 1550

Location(s):  FDA’s White Oak Campus in Silver Spring, Maryland

Travel Requirements: This position may require up to 25% travel.

Application Period:  Monday, June 21, 2021, through Friday, July 23, 2021

Salary: Salary starts at $122,530.00 and is commensurate with education and experience.

Conditions of Employment: United States Citizenship is required.

Special Notes: This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here.

Introduction:

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

     The mission of the Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by ensuring  that medical devices and radiation emitting products are safe and effective for people in the United States.  Within CDRH, the Office of Strategic Partnerships and Technology Innovation (OST or Office) provides leadership for all scientific collaborative and emerging technology related activities at CDRH.  Its Division of All Hazards Response, Science and Strategic Partnerships (DARSS) (DARSS)  is organization which  leads  all scientific collaboration efforts and emerging technology related activities at the Center.

We invite you to watch and listen as one of our CDRH colleagues shares his passion for the work he does, the Agency's pioneering regulatory science culture, opportunities for professional growth and career advancement, and why he loves working at CDRH by clicking here.

Position Summary:

As an experienced Cybersecurity specialist at CDRH,  you will join a dedicated and cohesive multidisciplinary team where you will have the opportunity to share your medical device security and safety expertise and build upon your scientific, technical, and regulatory knowledge by working with renowned cyber security, information security, threat prevention, and medical countermeasure experts. Your work will be essential in assisting the Office in ensuring the appropriate security of medical devices.  In this role, you will report to Assistant Director of the All Hazards Readiness, Response, and Cybersecurity Team (ARC or Team) and be challenged with assisting the Division and Team to develop policies that will allow for  safe and secure  medical devices. 

Duties/Responsibilities:

As a Cybersecurity Specialist you will perform the following duties:

  • With an intense focus on medical device safety, reliability, and protecting patient health information, you will utilize your cybersecurity expertise to provide policy input on regulatory submissions from industry, across the total product life cycle of networked, non-worked, and mobile medical devices to assess and evaluate potential threats and vulnerabilities, which could negatively impact the health of patients.
  • Collaborates with intra-Office cross-functional teams to develop health technology security standards, policies, and procedures related to regulatory review of medical devices and diagnostic equipment to minimize potential cybersecurity threats and to address vulnerabilities of networked, network capable, and mobile medical devices medical devices.
  • Serve as a scientific and technical consultant to Division and Office leadership, as well as industry, advisory panels, patient advisory organizations, and the health care community on trends, significant concerns, and reported adverse event regarding the identification of threats and vulnerabilities of medical devices and diagnostic equipment.
  • Proactively identify and share technology trends and emerging science that may influence and reshape cybersecurity decisions, recommended practices and technologies, medical device development and manufacturing, the medical device review process, and policy.
  • Conduct detailed assessments of product security analysis submissions involving medical device software, hardware, technologies involving radio-frequency identification (RFID), wired and mobile technology, and safety measures such as encryption and client/patient authentication.
  • Collaborate with Division and Office leadership to update or develop new regulations, processes, and protocols to address new regulatory pathways in the review of novel medical devices and diagnostic equipment with emerging technologies.  
  • Utilize cybersecurity expertise to critically assess medical device vulnerabilities and develop and implement optimal replicable strategies and solutions, using current and proven techniques and technologies to resolve these concerns.
  • Collaborate in the development of new strategies to address current and future cybersecurity concerns with Office colleagues across functional areas, industry, device manufacturers, healthcare providers, patients, staff, and other stakeholders in the medical device and cybersecurity communities.
  • Represent ARC at Division, Office, Center, working group, industry, patient advocacy, and scientific and professional meetings, where you will share your expertise regarding cybersecurity, medical device compromise, and threat mitigation.
  • Identify emerging technologies that could be used to improve medical device safety, reliability, and security to mitigate actual and/or potential cybersecurity threats and vulnerabilities.

Professional Experience/Key Requirements:

To qualify for this position, you must possess technical experience including:

  • Broad knowledge of medical devices, IT and cybersecurity infrastructure experience, and practical experience in applying techniques to mitigate security risks.
  • Knowledge and experience of security protection principles related to personal identifiable information, such as electronic health records, human research subject data from clinical trials, and clinical systems.
  • Ability to skillfully and effectively interpret and present complex scientific and technical cybersecurity information and concepts, in both written and oral formats, to diverse audiences.
  • Ability to contribute and work effectively in a team environment

Desirable Education:

Applicants with a Bachelor’s, Master’s, Ph.D., or an equivalent degree in computer science, cybersecurity, engineering, mathematics or related fields are highly desired.  Additionally, certifications from CompTIA, CEH, CBET, or SANS is preferred.

Basic Qualifications:

Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series

Conditions of Employment:

  • A probationary period may be required.
  • Background and/or Security investigation required.
  • S. citizenship is required.
  • All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
  • This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Equal Employment Opportunity Policy

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.

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.

Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:

  • An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
  • An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
  • An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

Learn more about disability employment and reasonable accommodations or how to contact an agency.

How to Apply:

Submit an electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “OST – 2021-LKI-03” in the subject line. Applications will be accepted through July 23, 2021.

Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.



Job Information

  • Job ID: 57358396
  • Location:
    Silver Spring, Maryland, United States
  • Position Title: Interdisciplinary Scientist (Cybersecurity Specialist)
  • Company Name: US Food & Drug Administration
  • Job Function: Other

Please refer to the company's website or job descriptions to learn more about them.

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