Description

General Summary: This role will serve as a technical authority and a Center-wide resource for our medical device review divisions. Specifically, you will be assigned to support the Office of Health Technology VII (OHT VII), which is responsible for the review of in vitro diagnostic (IVD) medical products.

Essential Job Functions:

• Serve as a scientific and technical cybersecurity 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.
• Focus on medical device safety, reliability, and protecting patient health information, you will utilize your vast cybersecurity expertise to provide policy input on regulatory submissions from industry, across the total product lifecycle of networked, non-networked, and mobile medical devices to assess and evaluate potential threats and vulnerabilities, which could negatively impact the health of patients.
• Provide expert guidance and share recommendations, with Team, Division, and Office leadership on medical device cybersecurity risks, protocols, processes, needs, and solutions.
• 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.
• 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 wireless network communications, mobile technology, and safety measures such as encryption and authentication.
• Support the review of COVID-19 diagnostics authorized for non-prescription, over-the-counter use (antigen, molecular, serology), which include IVD integration with digital tools via a mobile application, software, and wireless transmission of test results.
• As new technical challenges and opportunities emerge, help expedite interactive review processes and ensure high quality, safe and effective tests are reaching the market as quickly as possible.
• Contribute and work to combine cybersecurity expertise along with team members’ expertise in IVDs, microbiology, virology, medicine, public health, software, digital health, information technology, computing, and research and development.

Education Requirement: Bachelor of Science or equivalent degrees in Biomedical Engineering, Computer Engineering, Electronics Engineering, General Engineering, Computer Science, or related scientific fields.

Experience Requirement: 

• At least three (3) to five (5) years of experience in evaluating cybersecurity risks, threats and controls for embedded devices, mobile devices and/or cloud interfacing.
• Broad knowledge of medical devices 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.
• Certifications from CompTIA, CCSP, CEH, CISA, CISSP, CBET, and/or SANS are preferred.

Other Requirement(s): This position requires U.S. Citizenship or a Green Card holder and the ability to obtain and maintain a Government public trust level security clearance. For a candidate that is a Green Card holder, they must have lived in the United States for at least three out of the past five years prior to your application date. You will also meet the residency qualifications if you lived abroad while on government or military duty or if you were a dependent of a federal employee of military member.

Performance Requirements:

1. Excellent verbal and written communication skills.
2. Excellent interpersonal and customer service skills.
3. Extremely proficient in Microsoft Office Suite
4. Exceptional organizational skills and attention to detail.
5. Understanding of, or ability to quickly acquire, clerical procedures and systems such as recordkeeping and filing.
6. Ability to work independently.
7. Ability to establish and maintain effective and positive working relationships with all staff and visitors.

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Work performed in an office environment. Involves frequent contact with staff and customers.

Mental/Physical Requirements: Manual dexterity for office machine operation; stooping, bending to handle files and supplies, mobility to complete errands or deliveries. Must be able to remain in stationary position for extended periods of time. Stress can be triggered by multiple demands and deadlines.

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed. They are not intended to be an exhaustive list of all responsibilities, duties, skills, efforts, requirements, or working conditions. Management reserves the right to revise the job or to require that other or different tasks be performed as assigned in accordance with business demands and/or contractual requirements.