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Skills
- Analysis Skillsunmatched
- Biologyunmatched
- Biomedical Engineeringunmatched
- Clinical Researchunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Customer/Client Researchunmatched
- Data Analysisunmatched
- Design Servicesunmatched
- Documentationunmatched
- Drug Delivery Devicesunmatched
- Drug Productsunmatched
- Ergonomicsunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- Healthcareunmatched
- Human Factorsunmatched
- Human-Computer Interactionunmatched
- ISO (International Organization for Standardization)unmatched
- Industrial Engineeringunmatched
- International Electro-Technical Commission (IEC)unmatched
- Medical Equipmentunmatched
- Medical Treatmentunmatched
- Moderating Skillsunmatched
- Multitaskingunmatched
- Patient Careunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Product Reviewsunmatched
- Project/Program Managementunmatched
- Psychologyunmatched
- Qualitative Researchunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- Research Protocolsunmatched
- Risk Analysisunmatched
- Statisticsunmatched
- Technical Writingunmatched
- Usability Engineeringunmatched
- User Interface/Experience (UI/UX)unmatched
- Vendor/Supplier Managementunmatched
- Writing Skillsunmatched
Description
Responsibilities and Duties
Develop and maintain usability engineering documentation, including use-related risk analyses, task analyses, user profiles, use specifications, and human factors engineering reports.
Plan, conduct, and oversee human factors validation (summative) studies, including protocol development, participant recruitment, study moderation, data analysis, and report generation.
Collaborate with cross-functional internal teams and manage external vendors to deliver complicated human factors study projects and regulatory submission projects.
Support regulatory submissions by preparing human factors documentation and responding to regulatory authority questions related to usability and user safety.
Review product labeling, instructions for use (IFUs), training materials, and user interfaces to ensure clarity, consistency, and usability.
Required knowledge, skills, and experiences
Bachelor's degree in Human Factors Engineering, Human-Computer Interaction, Biomedical Engineering, Psychology, Industrial Engineering, Ergonomics, or a related field.
5+ years of experience in human factors engineering, usability engineering, user experience research, or a related discipline.
Experience conducting formative and summative usability studies.
Knowledge of FDA Human Factors Guidance (2016 & 2026), IEC 62366-1, ISO 14971, and applicable usability engineering principles.
Strong analytical, problem-solving, and technical writing skills.
Excellent verbal and written communication skills and the ability to work effectively in cross-functional teams.
Experience developing study protocols, moderator guides, risk analyses, and human factors reports.
Ability to manage multiple projects concurrently and work independently in a fast-paced environment.
Preferred Qualifications
Experience with combination products, drug delivery devices, digital health technologies, surgical systems, or other regulated medical devices.
Experience supporting regulatory submissions to FDA, EU MDR, or other global regulatory agencies.
Advanced degree (M.S. or Ph.D.) in Human Factors, Ergonomics, Psychology, Biomedical Engineering, or a related field.
Experience interacting with healthcare professionals, patients, and caregivers during user research activities.
Candidate with medical device design experience and clinical shadowing experienced is highly preferred.
Familiarity with statistical analysis and qualitative research methodologies.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $84,900.00 - $212,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Numbers & Facts
| Location | Washington, District of Columbia |
| Industry | Healthcare Services |
| Company Size | 10,000 employees or more |
| Year Founded | 1982 |
| Website | https://www.iqvia.com/ |
About Company
IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality.
It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers.
Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.