$0.00 - $200,000.00 /year relocation or travel expenses
Biomedical Engineer: Respiratory Devices This is a 5 year commitment; you may not need to relocate
About the Job
Biomedical Engineer: Respiratory Devices
This is a 5 year commitment; you may not need to relocate on a perm basis
This job requires an individual with strong biomedical engineering and design skills and experience with Respiratory Devices, no exceptions
We have a long term contract opportunity available for one of our U.S. Federal Government clients located in Washington, DC. This person is needed to provide advice, program management (PM) support, and mentorship to a government agency. This agency is responsible for developing and procuring medical countermeasures (MCM) against potential public health threats, to include natural occurring epidemic threats such as influenza as well as chemical, biological, radiological and nuclear threats. These technologies/products cross the gamut of vaccines, drugs, and devices.
Must be a US Citizen 160-180K, with relocation or commuting allowance.
Background: Be part of a team responsible for the 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. must careful 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. One specific medical product line within this larger portfolio is respiratory devices that serve as treatment support to patients who contract pulmonary diseases, be they weaponized or naturally occurring. This includes portable, rugged, and simple therapeutic devices that will be used in austere locations and often without direct medical personnel oversight. requires a subject matter expert who can provide necessary expertise in the engineering development, regulatory compliance, and clinical usage of such devices.
Tasks: This job requires an individual with strong biomedical engineering and design skills to assist in the following manner: •Conduct market surveys of medical respiratory devices against public health emergency response need and understanding the ramifications of technologies to environment, ease of use, and ultimate clinical usage requirements/satisfaction. •Assist in technology selection through review of technical proposals and providing recommendations to the project management team. •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 to schedule and then monitor progress periodically for compliance. •Assist in the management of contract to include assessment of contracted device manufacturer progress, technology or schedule risk identifications, and resolution recommendations.
Education: •Minimum: Bachelors in Biomedical Engineering •Preferred: Masters Degree in Biomedical Engineering •Real nice to have, PhD
Experience: •10 minimum, 15 + preferred years experience within a biomedical equipment/device discipline •At least 5 years within the medical device development/manufacturing of respiratory devices •Participated in a development team that took a respiratory device fully through FDA approval (510k minimum; IDE preferred). Understanding and participation with a regulatory team with emphasis on CMC data management. Interface with clinical staff to gain full needs into the design and function of the device. •Government expertise would be an added plus •Good written and oral communication skills are necessary
Please feel free to call 860 889 4141, until 9 PM Eastern, 7 days a week, after you have emailed a word doc resume directly to me
Regards, ciao, Namaste, Peace, Joe Joseph Anthony Vaccariello firstname.lastname@example.org