Biomedical Engineer / Medical Device Subject Matter Expert
to Support Respiratory and Medical Device and Diagnostics Development
Background: The DHHS is responsible for advanced development and procurement of medical
countermeasures to public health threats in the form of naturally occurring diseases such as influenza
and “weaponized” chemical, biological, and radiation terrorist actions. They complete this mission
through contracting actions to the industry that will develop, gain FDA approval and produce for storage
necessary countermeasures. DHHS must careful describe the need within solicitations and then upon
award of contract monitor progress against set cost, schedule, and performance guidelines. These
actions require subject matter experts in several different disciplines of medical pharmaceutical and
device development and manufacturing.
Within this larger portfolio are respiratory devices that can provide support to respiratory compromised
patients during pandemic influenza outbreaks or any all-hazards events. This includes durable reuseable medical devices and respiratory protection devices for use in austere locations and often
without direct medical personnel oversight. The DHHS requires a subject matter expert who can
provide necessary expertise in the engineering development, regulatory compliance, and clinical usage
of such devices.
The subject matter expert may also be assigned to support the development and manufacturing of other
medical devices and diagnostics that could be used counter CBRN, influenza and emerging infectious
disease threats.
Duties of the position: The DHHS requires an individual with strong biomedical engineering and design
skills to assist in the following manner:
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Conduct market surveys of respiratory protection and other medical device/diagnostic technologies
against public health emergency response need and understanding the ramifications of technologies
to environment, ease of use, and ultimate clinical usage requirements/satisfaction.
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Assist in technology selection from administration through review of technical proposals and
providing recommendations to the project management team.
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Assist in the preparation of solicitations for research projects to develop and manufacture
respiratory devices, from masks to ventilators, and other medical devices and diagnostics in support
of DHHS requirements.
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Understand regulatory implications of technologies and assist the Project Manager and contracted
manufacturer in developing a feasible and economical regulatory path with acceptable risk.
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Assist in the development of project plans – task to schedule and then monitor progress periodically
for compliance.
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Assist in the management of contract to include assessment of contracted device manufacturer
progress, technology or schedule risk identifications, and resolution recommendations.
Experience:
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Minimum of 10 (15+ years preferred) years of experience in biomedical
equipment/device development and manufacturing
At least 5 years of experience with development/manufacturing of respiratory devices
The desired candidate will have:
o Participated on a development team that took a respiratory device fully through
FDA approval (510(k) minimum; IDE preferred).
o An understanding of and experience with human factors engineering and testing
for medical devices
o Interfaced with clinical staff to establish and evaluate design and functional
requirements. Experience in development of design characteristics of
respiratory devices a definitive plus.
Excellent written and oral communication skills are necessary.
Ability to multi-task varying projects and activities to meet deadlines
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Minimum: Bachelors in Biomedical Engineering
Preferred: Master’s Degree in Biomedical Engineering
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Education: