Staff Fellow - Human Factors Engineer #2023-OHT3-Human Factors-002
The Center for Devices and Radiological Health (CDRH or Center), as the scientific and regulatory component of the U.S. Food and Drug Administration (FDA) charged with facilitating and ensuring medical device innovation, safety, and effectiveness, is now accepting applications for a Staff Fellow (Human Factors Engineer) to serve in the Office of Product Evaluation and Quality's (OPEQ) Office of Health Technology 3 (OHT3). This Staff Fellow position is located in the Division of Health Technology 3C (DHT3C or Division), specifically OPEQ's Human Factors Program (HFP).
POSITION SUMMARY: The HFP has an immediate opening for a Staff Fellow (Human Factors Engineer). Candidates should be well-versed in medical device development, medical device design optimization, human factor analysis, and medical device usability validation, safety, precision, and performance evaluation. As an integral member of the HFP, the Staff Fellow will collaborate with colleagues across the Center and provide expert consultation in the pre and post-market spaces in the review of medical devices and combination products, and conduct use-related analyses. Additionally, the Staff Fellow will evaluate the consistency and validity of industry reported information, as well as conduct real-world data assessments of medical device usage, patient and provider reported observations and outcomes, as well as advertisements and labeling claims related to the design and intended use of medical devices and combination products in patients.
DUTIES/ RESPONSIBILITIES: As a Staff Fellow (Human Factors Engineer), you will perform the following duties:
- Serve as an authoritative voice, technical expert, and resource on multidisciplinary teams to conduct human factors review of medical devices, combination products, and radiation-emitting diagnostic equipment.
- Utilize knowledge and experience of human factors to inform scientific and regulatory decisions.
- Communicate the importance of human factors input within the framework of the total product lifecycle review of medical devices, combination products, and radiation-emitting diagnostic equipment with industry, the clinical community, patient advocacy groups, the FDA, academia, and with other public health stakeholders.
- Advance knowledge and keep abreast of latest scientific trends, technologies, and techniques related to human factors.
- Provide expert consultation to Division and Office leadership on programmatic plans, health care community, scientific, and industry related trends, significant concerns, and adverse event reported data regarding medical devices, diagnostic equipment, and combination products regulated by the Center.
- Collaborate in the development, coordination, and implementation of policies and study designs to assure medical products, especially those novel in nature and with emerging technologies, are safe, effective, and reliable.
- Evaluate manufacturers' data to ascertain if mathematical and statistical methods, procedures, study design, and clinical claims presented are supported by validated statistical analysis and treatment data.
- Present reviews, conclusions, opinions, and recommendations to support product advisory panels, industry, and consultants on 510(k)s, PMAs, PDPs, De Novos, 513(g)s, and IDEs.
- Represent OHT3 at scientific, international standard organization, and other professional meetings, conferences, stakeholder meetings, working groups, and FDA advisory panels, as needed.
PROFESSIONAL EXPERIENCE / KEY REQUIREMENTS: To qualify for this position, you must demonstrate in your resume the necessary experience for this position, which is equivalent to the following:
- D. from an accredited university in Human Factors Engineering, Biomedical Engineering, General Engineering, Materials Engineering, Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, or related scientific fields.
- Demonstrated accountability and track record of delivering timely analysis, solution development, and resolutions through participation on cross-cutting teams for the benefit of decision-making leadership.
- Experience in evaluating the accuracy, precision, and reliability of medical devices, combination products, and diagnostic equipment.
- Ability to synthesize and evaluate data and information from a variety of sources, as well as the ability to identify and validate underlying causes, anticipate ancillary problems, and suggest appropriate courses of action.
- Ability to effectively interpret, assess, and communicate, both in oral and written formats, to a variety of audiences (e.g., scientific, management, policy makers) complex scientific information, methodology, and conclusions of scientific and technical analyses.
- Draft decisions and recommendations of national public health significance, which may impact the availability of certain products due to safety, efficacy, and reliability concerns.
- Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders.
PROFESSIONAL EXPERIENCE / KEY REQUIREMENTS: To qualify for this position, you must demonstrate in your resume the necessary experience for this position, which is equivalent to the following:
- D. from an accredited university in Human Factors Engineering, Biomedical Engineering, General Engineering, Materials Engineering, Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, or related scientific fields.
- Demonstrated accountability and track record of delivering timely analysis, solution development, and resolutions through participation on cross-cutting teams for the benefit of decision-making leadership.
- Experience as a strategic advisor with the ability to engage, build, and sustain relationships with internal and external stakeholders.
- Solution focused public health professional with superior project management and highly effective communication and scientific writing skills who can successfully lead and manage large-scale and long-range initiatives of national significance.
BASIC QUALIFCATIONS: Applicants must meet the specific qualification requirements of the following applicable occupational series: General Engineering (0801); Materials Engineering (0806); Mechanical Engineering (0830); Electrical Engineering (0850); Electronics Engineering (0855); Bioengineering and Biomedical Engineering (0858); Industrial Engineering (0896)
ADDITIONAL QUALIFICATIONS: To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).
FOREIGN EDUCATION: Candidates who have completed part or all of their education outside the United States must, in order to meet qualification requirements, have their foreign education evaluated by an accredited organization to ensure the foreign education is comparable to education received in the United States. It is the responsibility of the candidate or employee to provide written proof of her/his foreign education accreditation prior to appointment or placement in a different occupational series from which placed. For further information, visit the U.S. Department of Education - Foreign Education Evaluation.
CONDITIONS OF EMPLOYMENT
- One-year probationary period may be required.
- This position is for a three-year appointment and will be filled through FDA's Staff Fellowship Program
- Background and/or Security investigation
- Applicants who are U.S. Citizens and born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved
- This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For additional information, please visit the FDA Ethics and Integrity Office.
- All candidates must meet applicable security requirements which include a background check and a minimum of three (3) out of the past five (5) years' residency status in the US. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection, or appropriate disciplinary action.
- To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
LOCATIONS: FDA's White Oak Campus in Silver Spring, Maryland
BENEFITS: Salary is commensurate with education and experience. A comprehensive benefits package is offered to most Federal employees. For additional benefit information click here.
The United States Government equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor.