Biomedical Engineer/Medical Device Subject Matter Expert

Biomedical Engineer/Medical Device Subject Matter Expert

• Full-time

Location: Washington, D.C.

Experience: 10-15 years

Industry: Pharmaceutical / Biotech

Job Description:

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 carefully 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 re-usable 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:

1. Conduct market surveys of respiratory protection and other medical device/diagnostic technologies against public health emergency response needs, understanding the ramifications of technologies to environment, ease of use, and ultimate clinical usage requirements/satisfaction.
2. Assist in technology selection from administration through review of technical proposals and providing recommendations to the project management team.
3. 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.
4. Understand regulatory implications of technologies and assist the Project Manager and contracted manufacturer in developing a feasible and economical regulatory path with acceptable risk.
5. Assist in the development of project plans – task to schedule and then monitor progress periodically for compliance.
6. Assist in the management of contracts to include assessment of contracted device manufacturer progress, technology or schedule risk identifications, and resolution recommendations.

Experience:

1. Minimum of 10 (15+ years preferred) years of experience in biomedical equipment/device development and manufacturing.
2. At least 5 years of experience with development/manufacturing of respiratory devices.
3. Participated on a development team that took a respiratory device fully through FDA approval (510(k) minimum; IDE preferred).
4. Understanding of and experience with human factors engineering and testing for medical devices.
5. Interfaced with clinical staff to establish and evaluate design and functional requirements. Experience in development of design characteristics of respiratory devices is a definitive plus.
6. Excellent written and oral communication skills are necessary.
7. Ability to multi-task varying projects and activities to meet deadlines.

Education:

1. Minimum: Bachelor’s in Biomedical Engineering.
2. Preferred: Master’s Degree in Biomedical Engineering.

CANDIDATE DETAILS:

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

All your information will be kept confidential according to EEO guidelines.

Direct Staffing Inc