Tunnell Government Services

Role Description The successful candidate will be a Biomedical Engineer, with broad experience in aspects of the discipline that are relevant to the medical device domain, e.g., design, development, refinement, etc. They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions. Such submissions include: - Premarket Notification (510(k)) - Premarket Approval Application (PMA) The candidate should have demonstrated experience at the interface of advanced engineering and clinical medicine. Expertise in areas of research and development, quality and regulatory affairs, manufacturing and production, and clinical evaluation and field support should be evident. Additional specialization in relevant areas, such as: - Biomaterials - Biomechanics - Bioinstrumentation The candidate should be familiar with applicable industry standards and regulatory requirements, such as: - FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices) - US regulatory standards (21 CFR Part 820 -- Quality System Regulation) - ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices) Qualifications - Bachelor’s degree (BS) in biomedical engineering - Advanced degree (MS, PhD) in a related/applicable field is strongly preferred - 10 years of experience is required - Experience with directly supporting FDA 510(k) and related regulatory submissions is preferred - Exceptionally strong written and verbal communication skills - 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 - Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.) Requirements - Must be a US Citizen or Full Green Card holder Benefits - Full Time Employee - Schedule: Monday through Friday (No Holidays) - Location: This position is 100% telework

Role 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. - Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions). - Participate in meetings and teleconferences. - Coordinate meetings with internal and external stakeholders. - Develop written reviews and correspondence. - Perform research and conduct data analysis. - Write detailed documents and reports. - Execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and neurology, as relevant to medical devices used to diagnose, treat, and monitor neurological conditions, such as Parkinson’s disease, epilepsy, and traumatic brain injuries. Qualifications - Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - Current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least seven (7) years of relevant clinical experience. - Certification from a U.S. relevant specialty board organization (e.g., American Board of Psychiatry and Neurology). - Thorough understanding of current clinical practices in neurology, including diagnosis and treatment, and current/emerging trends in practice. - Preferred experience with neurological medical devices (e.g., deep brain stimulators, neurostimulators, neurointerventional devices, or exoskeletons for rehabilitation). - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 882 -- Neurological Devices), and guidances is preferred. - 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. Requirements - This position is 100% telework. Benefits - 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. - 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.

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. FDA CDRH – Medical Officer (Plastic Surgeon) 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 and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and plastic surgery, as relevant to medical devices. Requirements and Qualifications - The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least ten (10) years of relevant clinical experience - Certification from a U.S. relevant specialty board organization, e.g., the American Board of Plastic Surgery (ABPS), etc. - Thorough understanding of current clinical practices in plastic surgery, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of plastic surgery (e.g., aesthetic and body contouring devices [liposuction systems, energy-based skin tighteners, lasers], precision cutting and dissection tools (e.g., electrosurgical units, dermatomes, skin graft meshers), microsurgical equipment (operating microscopes, micro-instruments, doppler ultrasound), breast and implant-related tools (tissue expanders, keller funnel), craniofacial and bone tools (piezoelectric bone scalpels, internal fixation systems) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems. - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred. - 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. This position is 100% telework. Must be a US Citizen or a 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.

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. FDA CDRH – Medical Officer (Medical Oncologist) 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 and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and medical oncology, as relevant to medical devices. Requirements and Qualifications - The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least ten (10) years of relevant clinical experience - Certification from a U.S. relevant specialty board organization, e.g., certification in Medical Oncology by the American Board of Internal Medicine (ABIM), etc. - Thorough understanding of current clinical practices in medical oncology, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of oncology (e.g., treatment devices [infusion pumps, implantable venous access devices, aseptic formulation equipment] diagnostic and monitoring tools [imaging systems, biopsy tools, diagnostic sets, lab equipment], supportive and safety devices (oncology treatment chairs/beds, sterile processing equipment, defibrillators), advanced technologies (AI-based diagnostic software, interventional radiology tools). - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 864 – Hematology and Pathology, 21CFR Part 866 – Immunology and Microbiology), and guidances is preferred. - 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. This position is 100% telework. Must be a US Citizen or a 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.

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. Medical Officer (Orthopedic Surgeon) 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 and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and orthopedic surgery, as relevant to medical devices. Requirements and Qualifications - The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - In addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least fifteen (10) years of relevant clinical experience - Certification from a U.S. relevant specialty board organization, e.g., the American Board of Orthopedic Surgery (ABOS), etc. - Thorough understanding of current clinical practices in orthopedic surgery, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of orthopedic surgery (e.g., permanent and temporary implants [prostheses, fixation devices, osteobiologics], surgical instruments (e.g., bone cutting tools, preparation tools, soft tissue tools), enabling and smart technologies [robotic-assisted platforms, smart implants, AR/VR guidance, 3-D custom implants], and external fixation) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems. - Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred. - 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. This position is 100% telework. Must be a US Citizen or a 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.

Role Description The successful candidate will be an Engineer, with broad experience in aspects of the discipline that are relevant to the medical device domain, e.g., safety testing, design, and manufacturing, etc. They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc. - The candidate should have demonstrated experience as a systems engineer or product development engineer, as relevant to medical devices. - Expertise in areas of requirements and design input, risk management, verification and validation, cross-functional coordination, quality and documentation should be evident. - The candidate should be familiar with applicable industry standards and regulatory requirements, such as, but not limited to: - FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices) - US regulatory standards (21 CFR Part 820 -- Quality System Regulation) - ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices) Qualifications - The candidate must possess a bachelor’s degree (BS) in engineering. - An advanced degree (MS, PhD) in a related/applicable field is strongly preferred. - 10 years of experience is required. - Experience with directly supporting FDA 510(k) and related regulatory submissions is preferred. - Exceptionally strong written and verbal communication skills. - 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. - Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.). Requirements - The primary focus of the role is to support analyses of medical devices relative to regulatory and technical aspects of engineering. - Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions). - Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders. - Develop written reviews and correspondence. - Write detailed documents and reports. Benefits - Full Time Employee. - Schedule: Monday through Friday (No Holidays). - Location: This position is 100% telework. - Must be a US Citizen or a full Green Card holder.

Role Description The successful candidate will serve as a clinical and technical authority to a variety of internal and external stakeholders regarding an array of medical and radiological health products. They will provide scientific, technical, product development, and product validation advice as part of research protocol review, assessment of technical data included in regulatory submissions, as relevant to regulatory review of medical devices. Such submissions include: - Premarket Notification (510(k)) - Premarket Approval Application (PMA) Qualifications - Doctor of Veterinary Medicine (DVM) degree or equivalent - Unrestricted license to practice veterinary medicine in a state or territory of the United States - Additional advanced degrees (MS, PhD) or Board certifications in a related/applicable field are strongly preferred - 7 years of experience (clinical, academic, and/or industry experience) - General knowledge and experience with a variety of medical device development technical disciplines - Exceptionally strong written and verbal communication skills - Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel - Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.) Requirements - Provide expert consultant service in the area of Veterinary Medicine and use of animal models as related to Human Medical Device Regulatory Review - Apply expertise in the planning, conduct and review of animal studies used to validate the feasibility, safety and/or efficacy of medical devices - Participate in meetings to discuss device submissions with both internal and external sponsors - Write reviews and assist with development of other documents as needed - Assist OHT staff with projects in OPEQ’s OHTs including but not limited to: - Conducting interviews - Attending meetings - Data analysis - Communications with internal and external stakeholders - Writing drafts of internal and external communication Benefits - Full Time Employee - Schedule: Monday through Friday (No Holidays) - Location: 100% telework - Must be a US Citizen or a Full Green Card holder

Role Description The successful candidate will be an Engineer and Medical Device subject matter expert, with extensive experience involving device mechanical engineering. They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions that include mechanical functions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc. - Expertise in analyzing key components of the regulatory approach to assess device risk to patients and users. - Familiarity with device design and modeling, analysis and simulation, material selection, prototyping and testing, manufacturing, documentation, and human factors/ergonomics. - Knowledge of applicable industry standards and regulatory requirements, including FDA Guidances and US regulatory standards. - Experience in design and analysis of medical device systems, and performance of standardized device testing approaches. - Preparation of test plans and reporting of results. Qualifications - Bachelor’s degree (BS) in engineering, computer engineering, or a related field. - Advanced degree (MS, PhD) in a related/applicable field is strongly preferred. - 10 years of experience required (direct experience in medical device software and/or mechanical engineering). - General knowledge and experience with a variety of medical device development technical disciplines. - Experience with directly supporting FDA 510(k) and related regulatory submissions. - Exceptionally strong written and verbal communication skills. - Excellent interpersonal skills, with the ability to work independently and within a team. - Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.). Requirements - Support analyses of medical devices relative to regulatory and technical aspects of mechanical engineering. - Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions). - Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders. - Develop written reviews and correspondence. - Write detailed documents and reports. Job Type - Full Time Employee Schedule - Monday through Friday (No Holidays) Location - This position is 100% telework. - Must be a United States Citizen or a Full Green Card holder. Company Description 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role 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. - Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions). - Participate in meetings and teleconferences. - Coordinate meetings with internal and external stakeholders. - Develop written reviews and correspondence. - Perform research and conduct data analysis. - Write detailed documents and reports. - Execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and ophthalmology, as relevant to medical devices. Specific expertise involving surgical interventions, and sub-specialization in glaucoma and retinal disease is strongly preferred. Qualifications - Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - Current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least fifteen (15) years of relevant clinical experience. - Board Certification from the American Board of Ophthalmology. - Sub-specialization in glaucoma and/or retinal disease is strongly preferred. - Thorough understanding of current clinical practices in ophthalmology, including diagnosis and treatment, performance of ocular surgery, and current trends in practice. - Expert in function and utilization of ophthalmic medical devices, including specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices, intraocular lenses, glaucoma stents; and surgical systems, such as lasers and phacoemulsification machines. - Familiarity with FDA medical device regulatory processes and guidances is preferred. - 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. Requirements - This position is 100% telework. - Tunnell strives to hire and retain the most qualified talent. - 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. - 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role 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. In general, these consultants provide: - Consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions) - Participation in meetings and teleconferences - Coordination of meetings with internal and external stakeholders - Development of written reviews and correspondence - Writing detailed documents and reports - Execution of other administrative tasks related to CDRH’s projects Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and urology, as relevant to medical devices. Specific expertise involving surgical interventions, and sub-specialization in glaucoma and retinal disease is strongly preferred. Qualifications - Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States - Current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States - At least seven (7) years of relevant clinical experience - Board Certification from the American Board of Urology - Thorough understanding of current clinical practices in urology, including diagnosis and treatment, performance of surgery, and current trends in practice - Expert in function and utilization of the full range of medical devices and their accessories used in urological procedures (e.g., peripheral and sacral neurostimulators, surgical mesh for stress urinary incontinence, devices for treatment of voiding dysfunction, prostate cancer treatment devices, etc.) - Familiarity with FDA medical device regulatory processes and guidances is preferred - 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 Requirements - This position is 100% telework - Tunnell strives to hire and retain the most qualified talent - 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 - 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