Senior Human Factors Engineer (Project Management)
Job Summary
This position is responsible for leading and conducting Human Factor/Usability activities to ensure medical devices (Class I and Class II) are safe to use in various user environments. This engineer will collaborate with design engineers and divisional teams to improve the product designs (New and existing), specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for misuse and/or use errors. The engineer should be familiar with ISO 14971, ISO 62366, EN 60601-1-6, AAMI HE75, and general Medical Device and Healthcare regulations (21 CFR 820 and ISO 13485). Given general direction, execute with minimal supervisionJob Description
Responsibilities:
Working with internal and external resources, lead and 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.
Develop, implement, and advise product development teams of appropriate usability testing strategy. - Author and review 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, aEURA, uFMEA, 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.
Create, 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.).
Lead training workshops that focus on a variety of usability and human factors engineering subjects including insights distillation, concept generation, or solutions optimization to improve safety, risk mitigation, and/or user experience
Required Experience:
Education
Bachelor's degree in Engineering or Science
Work Experience
Minimum 4 years of Human Factor Engineering experience.
Preferred Qualifications:
Experience conducting usability studies and hazard analysis of use-related hazards,
Generate reports and recommendations for usability improvement.
Experience with industry standards regarding medical device human factors and usability (FDA, HE 75, ISO 62366) in the medical device development process.
Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
Experience with focus group, voice of customer, and human factor formative and summative studies.
Willing to travel up to 25% of the time for business purposes (domestic and international).
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:
$96,200.00 - $144,560.00 AnnualThe 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.
