Biomedical Engineer/Medical Device Subject Matter Expert

Direct Staffing

Full-time - Mid Level

Administrative and Support Services

About the position

The Biomedical Engineer/Medical Device Subject Matter Expert will support the Department of Health and Human Services (DHHS) in the advanced development and procurement of medical countermeasures against public health threats. This role focuses on respiratory devices that assist patients during pandemic outbreaks and other emergencies, requiring expertise in engineering development, regulatory compliance, and clinical usage of medical devices.

Responsibilities

• Conduct market surveys of respiratory protection and other medical device/diagnostic technologies against public health emergency response needs.
• Assist in technology selection from administration through review of technical proposals and provide recommendations to the project management team.
• 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.
• 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 the development of project plans, task scheduling, and monitor progress periodically for compliance.
• Assist in the management of contracts, including assessment of contracted device manufacturer progress, technology or schedule risk identifications, and resolution recommendations.

Requirements

• Minimum of 10 years of experience in biomedical equipment/device development and manufacturing (15+ years preferred).
• 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 definitive plus.
• Excellent written and oral communication skills are necessary.
• Ability to multi-task varying projects and activities to meet deadlines.

Nice-to-haves

• Master's Degree in Biomedical Engineering.