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Senior Biomedical Engineer
2 months ago
- Full-time
Location: Washington, D.C.
Experience: 10-15 years
Industry: Pharmaceutical / Biotech
Position Overview:
The Department of Health and Human Services (DHHS) is tasked with 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 partnerships with industry leaders who are responsible for the development, FDA approval, and production of essential countermeasures. The DHHS requires precise articulation of needs within solicitations and diligent monitoring of awarded contracts to ensure adherence to established cost, schedule, and performance metrics. This necessitates the involvement of subject matter experts across various disciplines in medical pharmaceutical and device development.
Key Responsibilities:
- Conduct comprehensive market assessments of respiratory protection and other medical device technologies relevant to public health emergency responses, considering environmental impacts, usability, and clinical satisfaction.
- Facilitate 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, in alignment with DHHS objectives.
- Comprehend regulatory implications associated with technologies and collaborate with project managers and manufacturers to establish viable regulatory pathways with acceptable risk profiles.
- Support the formulation of project plans, monitor compliance with timelines, and ensure adherence to project specifications.
- Oversee contract management, evaluating the progress of contracted manufacturers, identifying technology or schedule risks, and proposing resolutions.
Qualifications:
- Minimum of 10-15 years of experience in biomedical equipment/device development and manufacturing.
- At least 5 years of specialized experience in the development and manufacturing of respiratory devices.
- Experience on a development team that successfully navigated a respiratory device through FDA approval processes (510(k) minimum; IDE preferred).
- Proficient understanding of human factors engineering and testing methodologies for medical devices.
- Experience collaborating with clinical staff to define and assess design and functional requirements, particularly for respiratory devices.
- Exceptional written and verbal communication skills are essential.
- Demonstrated ability to manage multiple projects and meet deadlines effectively.
Educational Background:
- Bachelor's degree in Biomedical Engineering is required.
- Master's degree in Biomedical Engineering is preferred.
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