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Senior Biomedical Engineer

2 months ago

Washington, United States Direct Staffing Inc Full time
Biomedical Engineer/Medical Device Subject Matter Expert
  • Full-time

Location: Washington, D.C.

Experience: 10-15 years

Industry: Pharmaceutical / Biotech

Position Overview:

The Department of Health and Human Services (DHHS) plays a critical role in the advanced development and procurement of medical countermeasures to address public health threats, including naturally occurring diseases and potential bioterrorism. This mission is accomplished through strategic contracting with industry partners to develop, secure FDA approval, and produce essential countermeasures for storage.

To fulfill this mission, DHHS requires detailed specifications in solicitations and must monitor awarded contracts to ensure adherence to cost, schedule, and performance benchmarks. This necessitates the involvement of subject matter experts across various disciplines in medical pharmaceutical and device development.

Among the diverse portfolio of responsibilities are the development of respiratory devices designed to assist patients with compromised respiratory function during public health emergencies, such as pandemic influenza or other hazardous events. This includes both durable, reusable medical devices and respiratory protection equipment intended for use in challenging environments, often without direct medical oversight. The DHHS seeks a subject matter expert to provide essential guidance in the engineering development, regulatory compliance, and clinical application of these devices.

The expert may also contribute to the development and manufacturing of additional medical devices and diagnostics aimed at countering chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases.

Key Responsibilities:

  1. Conduct comprehensive market analyses of respiratory protection and other medical device technologies in relation to public health emergency response needs, considering environmental impacts, usability, and clinical satisfaction.
  2. Support technology selection processes from initial administration through the evaluation of technical proposals, providing informed recommendations to project management.
  3. Assist in drafting solicitations for research initiatives aimed at developing and manufacturing respiratory devices, including masks and ventilators, alongside other medical devices and diagnostics in alignment with DHHS requirements.
  4. Understand the regulatory landscape of technologies and collaborate with project managers and manufacturers to devise feasible and cost-effective regulatory pathways with acceptable risk levels.
  5. Contribute to the formulation of project plans, establishing tasks and schedules, and periodically monitor compliance with these plans.
  6. Oversee contract management, including evaluating the progress of contracted manufacturers, identifying technology or schedule risks, and recommending resolutions.

Qualifications:

  1. Minimum of 10-15 years of experience in biomedical equipment/device development and manufacturing.
  2. At least 5 years of experience specifically in the development and manufacturing of respiratory devices.
  3. Experience on a development team that successfully guided a respiratory device through the FDA approval process (510(k) minimum; IDE preferred).
  4. Knowledge of human factors engineering and testing methodologies for medical devices.
  5. Experience collaborating with clinical teams to define and assess design and functional requirements, with a focus on respiratory device design.
  6. Strong written and verbal communication skills are essential.
  7. Ability to manage multiple projects and tasks effectively to meet deadlines.

Education:

  1. Minimum: Bachelor's degree in Biomedical Engineering.
  2. Preferred: Master's degree in Biomedical Engineering.

CANDIDATE DETAILS:

  • 15+ years of experience
  • Management Experience Required - No
  • Minimum Education - Bachelor's Degree
  • Willingness to Travel - Occasionally

All candidate information will be maintained confidentially in accordance with EEO guidelines.

Direct Staffing Inc