Biomedical Engineer/Medical Device Subject Matter Expert - Washington - Direct Staffing Inc

Direct Staffing Inc Washington

4 days ago

Description

Biomedical Engineer/Medical Device Subject Matter Expert

Full-time

Location: Washington, D.C.

Experience: 10-15 years

Industry: Pharmaceutical / Biotech

Job Description:

The Department of Health and Human Services (DHHS) is responsible for developing and procuring medical countermeasures to address public health threats, including naturally occurring diseases and 'weaponized' chemical, biological, and radiation terrorist actions.

This mission involves contracting with industry partners to develop, gain FDA approval, and produce necessary countermeasures. DHHS must carefully describe the need within solicitations and monitor progress against set cost, schedule, and performance guidelines.

Within this portfolio are respiratory devices that provide support to patients during pandemic influenza outbreaks or all-hazards events, including durable re-usable medical devices and respiratory protection devices for use in austere locations without direct medical oversight.

DHHS requires a subject matter expert who can provide expertise in engineering development, regulatory compliance, and clinical usage of such devices.

The subject matter expert may also support the development and manufacturing of other medical devices and diagnostics for countering CBRN, influenza, and emerging infectious disease threats.

Duties of the Position:

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

Experience:

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

Education:

Minimum: Bachelor's in Biomedical Engineering.
Preferred: Master's Degree in Biomedical Engineering.

Candidate Details:

15+ years experience
No Management Experience Required
Minimum Education - Bachelor's Degree
Occasional Travel

All information will be kept confidential according to EEO guidelines.

Direct Staffing Inc

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