Senior Biomedical Engineer
2 weeks ago
- 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. These threats can arise from naturally occurring diseases, such as influenza, or from deliberate actions involving chemical, biological, or radiological terrorism. The DHHS fulfills its mission through strategic contracting with industry partners to develop, secure FDA approval, and produce essential countermeasures for stockpiling.
To effectively carry out this mission, DHHS requires the expertise of subject matter experts across various disciplines in medical pharmaceuticals and device development. This includes a focus on respiratory devices designed to assist patients with compromised respiratory function during pandemic situations or other emergency events. These devices encompass durable, reusable medical apparatus and respiratory protection equipment suitable for use in challenging environments, often without direct medical oversight.
Key Responsibilities:
- Conduct comprehensive market assessments of respiratory protection and other medical device technologies to meet public health emergency response needs, considering environmental impacts, usability, and clinical satisfaction.
- Support technology selection processes by reviewing technical proposals and providing informed recommendations to project management.
- Assist in drafting solicitations for research initiatives aimed at developing and manufacturing respiratory devices, including masks and ventilators, as well as other medical devices and diagnostics aligned with DHHS requirements.
- Understand and navigate the regulatory landscape related to technologies, aiding project managers and manufacturers in establishing feasible regulatory pathways with acceptable risk levels.
- Contribute to the development of project plans, ensuring tasks are scheduled and progress is monitored for compliance.
- Manage contracts by evaluating the progress of contracted manufacturers, identifying technology or schedule risks, and recommending resolutions.
Qualifications:
- Minimum of 10-15 years of experience in biomedical equipment/device development and manufacturing.
- At least 5 years of experience specifically in the development and manufacturing of respiratory devices.
- Experience on a development team that successfully guided a respiratory device through the FDA approval process (510(k) minimum; IDE preferred).
- Knowledge of human factors engineering and testing methodologies for medical devices.
- Experience collaborating with clinical staff to define and assess design and functional requirements, with a strong emphasis on respiratory device design.
- Exceptional written and verbal communication skills are essential.
- Ability to manage multiple projects and tasks effectively to meet deadlines.
Educational Background:
- Minimum: Bachelor's degree in Biomedical Engineering.
- Preferred: Master's degree in Biomedical Engineering.
Candidate Profile:
- 15+ years of relevant experience.
- Management experience is not required.
- Minimum educational requirement: Bachelor's degree.
- Willingness to travel occasionally.
All candidate information will be kept confidential in accordance with EEO guidelines.
Direct Staffing Inc
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