Responsible for execution of the human factor engineering (HFE) program to ensure devices (Class I and Class II) are safe to use in various user environments: Reviewing and deriving HFE requirements, integrating HFE into device design activities to be safe and effective for use by intended users. Job Description Responsibilities: Working with internal and external resources, execute user research, focus groups, preference tests, and usability studies (formative and summative) in support of all product development stages. Planning, organizing, recruiting, and executing usability evaluations. Drafting use scenarios, task analyses, critical task lists, surveys, and moderator scripts. Conducting observational, face to face, and video/telephone interviews with healthcare professionals in a range of healthcare settings. Data collection, analysis, and generation of documentation. Conduct user research and distill insights into themes that guide user needs, user risks, and user interface design. Document intended users and use environments in use specifications. Support to develop, implement, and advise product development teams of appropriate usability testing strategy. - Author protocols and reports in support of product development activities, design control requirements, product validation, risk assessments, and regulatory filings (global). Collaborate with product design teams to optimize device design and mitigate risks related to misuse and/or use errors. Contribute to use-related risk analysis and implement control measures (URRA, aFMEA, and/or Hazard Analysis). Using human factor engineering methodologies, analyze data trends, generate reports, and identify product opportunities based on user feedback/studies. Leverage data to provide directional guidance to product designs teams. Review, and update internal procedures and/or templates to comply with the latest industry standards and regulations (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, etc.). Required Experience: Education Bachelor’s degree in Engineering or Science. Work Experience At least 2 years of Human Factor engineering experience. Willing to travel up to 25% of the time for business purposes (domestic and international). Preferred Qualifications: Experience conducting usability studies and hazard analysis of use-related hazards, Familiarity with industry standards regarding medical device human factors and usability (FDA, HE 75, ISO 62366) in the medical device development process. Knowledge of user centered design and human factors principles. Experience working with cross functional teams Experience with focus group, voice of customer, and human factor formative and summative studies. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $85,000.00 - $128,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.
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Job Type
Full-time
Career Level
Mid Level