FDA CDRH - Medical Device Decontamination SME Position Description The mission of the FDA Center ... Please be advised that certain client contracts may outline specific requirements for onsite work.
FDA CDRH - Medical Device Decontamination SME Position Description The mission of the FDA Center ... Please be advised that certain client contracts may outline specific requirements for onsite work.
FDA CDRH - Medical Device Decontamination SME Position Description The mission of the FDA Center ... Please be advised that certain client contracts may outline specific requirements for onsite work.
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FDA CDRH - Medical Device Decontamination SME Position Description The mission of the FDA Center ... Please be advised that certain client contracts may outline specific requirements for onsite work.
Contracts & Proposal Senior Analyst
Leesburg, VA ยท On-site
$100K/yr
Familiarity with medical device sales structures, including GPOs, IDNs, and hospital systems. * Proficiency with CRM and contract lifecycle management (CLM) tools (e.g., Salesforce, Conga, Ironclad ...
Contracts & Proposal Senior Analyst
Leesburg, VA ยท On-site
$100K/yr
Familiarity with medical device sales structures, including GPOs, IDNs, and hospital systems. * Proficiency with CRM and contract lifecycle management (CLM) tools (e.g., Salesforce, Conga, Ironclad ...
Ability to Obtain Public Trust Our client is striving to transform medical device countermeasures ... U.S. citizenship or permanent residency (required for federal contract work). * Hybrid role ...
Ability to Obtain Public Trust Our client is striving to transform medical device countermeasures ... U.S. citizenship or permanent residency (required for federal contract work). * Hybrid role ...
International Medical Device Countermeasures (MCM) Data SME
Silver Spring, MD ยท On-site
$98K - $163K/yr
Ability to Obtain Public Trust Our client is striving to transform medical device countermeasures ... U.S. citizenship or permanent residency (required for federal contract work). * Hybrid role ...
International Medical Device Countermeasures (MCM) Data SME
Silver Spring, MD ยท On-site
$98K - $163K/yr
Ability to Obtain Public Trust Our client is striving to transform medical device countermeasures ... U.S. citizenship or permanent residency (required for federal contract work). * Hybrid role ...
Silver Spring, MD (Onsite) Duration: 06 months contract (High potential for extension) Job Summary ... Support equipment lifecycle validation activities for commercial medical device operations
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Silver Spring, MD (Onsite) Duration: 06 months contract (High potential for extension) Job Summary ... Support equipment lifecycle validation activities for commercial medical device operations
Medical Device Account Executive - VA / WV / MD / DC
Washington, DC ยท On-site +1
$220K/yr
Negotiate contracts and pricing with the RSD and/or CCO * Maintain their customer details in our ... as Medical Device, SaaS or healthcare software sales knowledge preferred * Clinical aptitude ...
Medical Device Account Executive - VA / WV / MD / DC
Washington, DC ยท On-site +1
$220K/yr
Negotiate contracts and pricing with the RSD and/or CCO * Maintain their customer details in our ... as Medical Device, SaaS or healthcare software sales knowledge preferred * Clinical aptitude ...
Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
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Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
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Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
Quick apply
Medical Support Assistant
Washington, DC ยท On-site
$45K - $58K/yr
Medical Support Assistants (MSAs) Federal contract opportunity URGENTLY seeking experienced Medical ... Medical Device, Construction/Engineering, Government & Critical Infrastructure. Contracting ...
Senior Staff Packaging Engineer
Leesburg, VA ยท On-site
$128K - $136K/yr
Lead the design, development, and implementation of sterile and non-sterile medical device ... Collaborate with suppliers and contract manufacturers to optimize packaging designs, improve ...
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Senior Staff Packaging Engineer
Leesburg, VA ยท On-site
$128K - $136K/yr
Lead the design, development, and implementation of sterile and non-sterile medical device ... Collaborate with suppliers and contract manufacturers to optimize packaging designs, improve ...
Senior Staff Packaging Engineer
Leesburg, VA ยท On-site
$128K - $136K/yr
Lead the design, development, and implementation of sterile and non-sterile medical device ... Collaborate with suppliers and contract manufacturers to optimize packaging designs, improve ...
Senior Staff Packaging Engineer
Leesburg, VA ยท On-site
$128K - $136K/yr
Lead the design, development, and implementation of sterile and non-sterile medical device ... Collaborate with suppliers and contract manufacturers to optimize packaging designs, improve ...
Vision Scientist
Bethesda, MD ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
Vision Scientist
Bethesda, MD ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
Vision Scientist
Washington, DC ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
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Vision Scientist
Washington, DC ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
Vision Scientist
Bethesda, MD ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
Vision Scientist
Bethesda, MD ยท On-site
Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD ... The Division carries out scientific and end-to-end medical device review evaluation, including ...
... contract on-site, Falls Church, VA. Responsibilities: * Provide medical logistics policy and ... for medical device and pharmaceutical domains * Provide support in formulating joint medical ...
... contract on-site, Falls Church, VA. Responsibilities: * Provide medical logistics policy and ... for medical device and pharmaceutical domains * Provide support in formulating joint medical ...
... contract on-site, Falls Church, VA. Responsibilities: * Provide medical logistics policy and ... for medical device and pharmaceutical domains * Provide support in formulating joint medical ...
... contract on-site, Falls Church, VA. Responsibilities: * Provide medical logistics policy and ... for medical device and pharmaceutical domains * Provide support in formulating joint medical ...
... of in vitro diagnostic and device medical countermeasures specific to influenza, emerging ... Support BARDA in the review of contract-related documents, including regulatory strategy ...
... of in vitro diagnostic and device medical countermeasures specific to influenza, emerging ... Support BARDA in the review of contract-related documents, including regulatory strategy ...
Serve as a key point of contact for contract medical monitoring vendors (e.g., medical monitoring ... device; and extensive reading. * The worker is not substantially exposed to adverse environmental ...
Serve as a key point of contact for contract medical monitoring vendors (e.g., medical monitoring ... device; and extensive reading. * The worker is not substantially exposed to adverse environmental ...
Mobile Device Engineer II
Washington, DC ยท On-site
$38.44/hr
Contract To Hire Compensation: $38.44 (Pay Rate Low) Work Model: Onsite - onsite Hours: 40.0 ... medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as ...
Quick apply
Mobile Device Engineer II
Washington, DC ยท On-site
$38.44/hr
Contract To Hire Compensation: $38.44 (Pay Rate Low) Work Model: Onsite - onsite Hours: 40.0 ... medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as ...
Contract Medical Device information
See Reston, VA salary details
$22.26 - $29.37
5% of jobs
$36.22 is the 25th percentile. Wages below this are outliers.
$29.37 - $36.49
21% of jobs
$36.49 - $43.61
21% of jobs
The median wage is $46.37 / hr.
$43.61 - $50.72
9% of jobs
$50.72 - $57.84
16% of jobs
$59.62 is the 75th percentile. Wages above this are outliers.
$57.84 - $64.95
11% of jobs
$64.95 - $72.07
6% of jobs
$72.07 - $79.19
7% of jobs
$79.19 - $86.30
2% of jobs
$86.30 - $93.42
1% of jobs
$93.42 - $100.53
0% of jobs
$22
$51
$100
How much do contract medical device jobs pay per hour?
What are the key skills and qualifications needed to thrive as a contract medical device engineer?
What is a contract medical device professional?
What are some common challenges faced by contract medical device professionals and how can they be addressed?
Full-time
Posted 15 days ago
Job description
FDA CDRH - Medical Device Decontamination SME Position Description
The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices.
Responsibilities:
- Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise, experience, and training in the field of decontamination/sterilization, as relevant to medical devices and device related combination products.
- The primary focus of the role is to provide regulatory and technical support to CDRH in the review and disposition of submittals from the medical device decontamination/sterilization industry to include review of 510(k) submissions, consultations, Pre-Submission (Q-Sub) engagements, among others. The candidate will use a combination of technical and operational expertise along with extensive review of FDA guidance documents and standard test methods relevant to each product to conduct a review of each submission, with a goal of ensuring that the product is safe and effective
- Participate in meetings and teleconferences, coordinate meetings with internal and external stakeholders related to marketing applications and pre-submissions
- Support ancillary, prioritized activities in support of the agency, such as performing review of Medical Device Reporting (MDR) submittals
- Develop written reviews and correspondence
- Write detailed documents and reports
Skills and Qualifications:
- The candidate must possess a bachelor's degree (BS in a scientific/technical discipline applicable to sterilization/decontamination)
- An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
- At least 15 years of experience is required (direct experience in decontamination/sterilization involving medical products)
- Experience with FDA Sterilization/Decontamination Guidance and other US regulatory requirements and consensus standards (ISO, ANSI) for medical devices highly preferred.
- Candidate must be able to apply knowledge of decontamination/sterilization to the assessment of medical devices. This must entail an advanced understanding of the various techniques and industry best practices involving technologies to include fumigants, radiation, use of heat/steam, disinfectants, and validation approaches, e.g., indicators.
- The ability to read and interpret standards, as well as knowledge of validation and testing methods related to sterilization, biocompatibility, shelf life, and performance testing, is critical.
- Ability to communicate well with others using excellent written and verbal communication skills.
- Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
Must be a US Citizen or Full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.