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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 crucial role in the advanced development and procurement of medical countermeasures aimed at addressing public health threats, including naturally occurring diseases and potential terrorist actions involving chemical, biological, and radiological agents. This mission is executed through strategic contracting with industry partners who are tasked with developing, securing FDA approval, and producing essential countermeasures for storage.

To fulfill this mandate, DHHS requires skilled subject matter experts across various disciplines related to medical pharmaceuticals and device development. A significant focus is placed on respiratory devices designed to assist patients with compromised respiratory function during pandemic situations or other emergency events. This encompasses durable, reusable medical devices and respiratory protection equipment intended for use in challenging environments, often without direct medical oversight.

Key Responsibilities:

  1. Conduct comprehensive market assessments of respiratory protection and other medical device technologies to align with public health emergency response needs, considering environmental impact, usability, and clinical satisfaction.
  2. Support technology selection processes by reviewing technical proposals and 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, in accordance with DHHS requirements.
  4. Understand and navigate the regulatory landscape associated with medical technologies, aiding project managers and manufacturers in establishing viable regulatory pathways with acceptable risk levels.
  5. Contribute to the formulation of project plans, ensuring tasks are scheduled and progress is monitored for compliance.
  6. Manage contracts effectively, evaluating the progress of contracted manufacturers, identifying risks related to technology or timelines, and proposing 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 navigated a respiratory device through the FDA approval process (510(k) minimum; IDE preferred).
  4. Familiarity with human factors engineering and testing methodologies for medical devices.
  5. Experience collaborating with clinical staff to define and assess design and functional requirements, particularly for respiratory devices.
  6. Strong written and verbal communication skills are essential.
  7. Ability to manage multiple projects and activities effectively to meet deadlines.

Educational Background:

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

Candidate Profile:

  • 15+ years of relevant experience.
  • Management experience is not required.
  • Minimum educational requirement is a Bachelor's degree.
  • Willingness to travel occasionally.

All information will be kept confidential in accordance with EEO guidelines.

Direct Staffing Inc