Biomedical Engineer/Medical Device Subject Matter Expert

2 days ago

Washington DC United States Direct Staffing Inc Full time
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

#J-18808-Ljbffr

  • Biomedical Engineer

    4 weeks ago

    Long Beach, CA, United States Oxford Global Resources Full time

    Duties:Develop and implement a comprehensive medical equipment management program that complies with applicable healthcare standards, regulatory agencies, and industry best practices.Create and deliver a curriculum for a continuing education program focused on the safe and effective use of medical technology for healthcare staff.Manage a recall and safety...

  • Subject Matter Expert

    2 days ago

    Washington, DC, United States Ladgov Full time

    Job title: Subject Matter Expert Location: Washington, DC Schedule: full time Qualification: Master’s Degree or equivalent experience. 10 years of experience in a specialized topic related to health and social services recovery. Proven expertise in program planning, assessment, and evaluation. Strong practical experience and theoretical knowledge in...

  • SVTC Engineering Subject Matter Expert IV

    2 days ago

    Washington, DC, United States Invictus International Consulting, LLC. Full time

    Title: SVTC Engineering Subject Matter Expert IV Location: Washington, D.C. Clearance: TS/SCI with the ability to obtain and maintain a CI polygraph Job Details: Generally recognized as a leader in the industry in their area of expertise; sought out by others in the area of expertise for advice and guidance Provide expert support, analysis,...

  • SVTC Engineering Subject Matter Expert IV

    16 hours ago

    Washington, DC, United States ZipRecruiter Full time

    Title: SVTC Engineering Subject Matter Expert IV Location: Washington, D.C. Clearance: TS/SCI with the ability to obtain and maintain a CI polygraph Job Details: Generally recognized as a leader in the industry in their area of expertise; sought out by others in the area of expertise for advice and guidance. Provide expert support, analysis, research,...

  • Biomedical Engineer

    4 weeks ago

    Madison, WI, United States Seneca Resources Full time

    Job Description:As a Biomedical Engineer, you will help ensure today is safe and tomorrow is smarter. Our work depends on Biomedical Engineer joining our team to provide exceptional health care that improves Veteran health and well-being. This mission guides the Office of Healthcare Technology Management’s (HTM) support for patient care to provide the...

  • Policy and Strategy Subject Matter Expert

    17 hours ago

    Washington, DC, United States BryceTech LLC Full time

    Policy and Strategy Subject Matter Expert Full-time BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools,...

  • Senior Information Assurance Subject Matter Expert

    2 days ago

    Washington, DC, United States ARA Full time

    Senior Information Assurance Subject Matter Expert Washington, District of Columbia, United States The Capital Area Division (CAD) of Applied Research Associates, Inc. (ARA) is seeking an energetic Senior Information Assurance (IA) Subject Matter Expert (SME) to support the Navy in the development and application of cutting-edge high-performance computing...

  • Subject Matter Expert I

    4 weeks ago

    Washington, United States RWD Consulting, LLC Full time

    REQUIRED: Minimum Secret Security Clearance; but TOP-Secret Clearance preferred The Subject Matter Expert (SME) will be part of the EUR-NEA Israeli-Palestinian-North Africa (IPNA) team with a focus on the Gaza Crisis Response, and the post-October 7 humanitarian crisis impacting Palestinians in Gaza and the greater Middle East region. The SME will assist the...

  • Subject Matter Expert I

    2 days ago

    Washington, DC, United States Catawbacorps Full time

    Job Title: Subject Matter Expert I Job Type: Full-time Location: DC US (Primary) Category: Marketing/Communications Education: High School Travel: Required Job Description: The contractor shall provide regular and/or daily support to EM-2.3, 2.31 and 2.32. Services will include communications support, key document rollout, analysis and...

  • Regional Subject Matter Expert

    17 hours ago

    Washington, DC, United States Booz Allen Hamilton Full time

    Job Number: R0201848 Regional Subject Matter Expert The Opportunity: It takes a skilled intelligence expert to know how to find and interpret the best data to give their clients the right answers. To support the critical decisions made in the Department of Defense (DoD) every day, we need an Intelligence Professional like you to do just that. At Booz...

  • Subject Matter Expert Professional

    7 days ago

    Washington, Washington, D.C., United States Mele Accociates Full time

    Job Description:A highly skilled Subject Matter Expert II is sought to support the Department of Energy's State and Community Energy Programs.This role requires a PhD in an appropriate discipline or a Master's degree with relevant experience and a DOE L or Q clearance.The expert will provide consulting, analysis, and support on critical issues, work...

  • Subject Matter Expert

    2 weeks ago

    Washington, United States Quantic School of Business and Technology Full time

    Quantic School of Business and Technology is looking for a subject matter expert in Marketing to support online EMBA, MBA and CMO Certificate students in understanding Marketing-related content.The Subject Matter Expert (SME) will draw on their PhD level education and experience, as well as a review of Quantic’s Marketing content to provide students with...

  • Subject Matter Expert

    2 weeks ago

    Washington, United States Quantic School of Business and Technology Full time

    Quantic School of Business and Technology is looking for a subject matter expert in Marketing to support online EMBA, MBA and CMO Certificate students in understanding Marketing-related content.The Subject Matter Expert (SME) will draw on their PhD level education and experience, as well as a review of Quantic’s Marketing content to provide students with...

  • Senior Acquisition Subject Matter Expert

    15 hours ago

    Washington, DC, United States C&G Consulting, Inc. Full time

    C & G is seeking a Senior Acquisition Subject Matter Expert (SME) to provide acquisition subject matter expertise to the PM, DPM, or Principal Acquisition Program Managers (PAPM) as requested to support the Government Cost Realism Analyst. Education/ Experience Requirements: A minimum of twenty (20) years of professional experience supporting an ACAT I...

  • Subject Matter Expert

    18 hours ago

    Baltimore, MD, United States EmergencyMD Full time

    Enjoy problem-solving, need a venue to display your creativity, and emerging technologies pique your interest; if so, Barrow Wise Consulting, LLC is for you. As a multi-disciplined leader, you understand the gifts that set you apart from everyone else. Demonstrate innovative solutions to our clients. Join Barrow Wise Consulting, LLC today. Responsibilities: ...

  • Subject Matter Expert III

    2 days ago

    Washington, DC, United States BVG & Company Full time

    The Subject Matter Expert III (SME III) full-time position supports the headquarters staff for a U.S. Federal agency and its stakeholders. In support of the agency’s mission, the SME III is responsible for providing strategic technical expertise for all major capability areas, developing next-generation business opportunities, and is responsible for...

  • Nuclear Subject Matter Expert

    4 weeks ago

    Washington, Washington, D.C., United States JGMS Government Services, LLC Full time

    Job DescriptionJob Title: Senior Nuclear Technology Subject Matter ExpertJob Summary:JGMS Government Services, LLC is seeking a highly experienced Nuclear Subject Matter Expert to support the Department of Energy, National Nuclear Security Administration, Assistant Deputy Administrator for Research, Development, Test, & Evaluation (NA-11).Key...

  • Subject Matter Expert II

    1 week ago

    Washington, United States Mele Accociates Full time

    MELE Associates, Inc. is seeking to add an experienced Subject Matter Expert II team member to support the Department of Energy (DOE) State and Community Energy Programs (SCEP). The Subject Matter Expert II position is located at the Department of Energy Forrestal Building, Washington, DC. This full-time position is contingent upon contract award.Essential...

  • Video Teleconference Subject Matter Expert

    18 hours ago

    Washington, DC, United States Tygart Technology, Inc. Full time

    Tygart is currently identifying candidates for a Video Teleconference Subject Matter Expert (SME) position, to support cabling design and engineering initiatives for a DOJ customer. This position requires that the candidate have a current Top Secret security clearance.Responsibilities include but not limited to the following: Capturing the requirements for...

  • Cybersecurity ~ Subject Matter Functional Expert

    16 hours ago

    Washington, DC, United States Kaizen Lab Inc. Full time

    Cybersecurity ~ Subject Matter Functional Expert (SME) Rapid Strategy is seeking a Cybersecurity SME for a Federal project. Rapid Strategy is an award-winning and African-American owned small business providing cybersecurity services to the private and public sector. Based in Charlotte, NC, we support our clients across the North Carolina and DMV area. You...