Job SummaryThis position is responsible for leading Human Factors and Usability Engineering activities across the product lifecycle to ensure medical devices (Class I and II) are safe and effective for use. This engineer will collaborate with cross-functional project teams to improve product designs (new and existing), specifically the device user interfaces, including the device, packaging, labeling, and instructions for use, while minimizing the potential for use errors. This position will advise on and oversee completion of Design Validation activities, including execution of simulated use studies, to ensure devices meet user needs and intended uses. This position mentors engineers and leads process improvement initiatives.
Job DescriptionResponsibilities:- Lead Human Factors activities across the product lifecycle, from early concept through development, validation, and post-market surveillance. Develop and implement usability strategies and provide guidance to product development teams.
- Lead and execute usability studies (formative and summative) with end users across all stages of product development. Author protocols, surveys, use scenarios, moderator scripts, and reports.
- Conduct user research, including contextual inquiries and heuristic analyses, and distill insights into themes that guide user needs, use-related risks, and user interface design. Collaborate with product design teams to establish user needs.
- Create and maintain usability engineering documentation to record human factors activities, including use specifications, usability plans, and summary reports.
- Identify and assess potential use errors and hazards through task analysis, review of known use problems, and risk assessments. Advise product development teams on human factors considerations to optimize device design and mitigate risks associated with misuse or use errors. Create use-related risk analysis documentation and implement risk control measures.
- Lead Design Validation activity planning, execution, and completion of documentation. Conduct Design Validation simulated use studies to support Design Validation efforts. Collaborate with cross-functional teams to develop methods for and ensure completion of all Design Validation deliverables.
- Create, review, and update internal team and corporate procedures and templates to comply with current industry standards and regulations.
- Lead training workshops on usability and human factors engineering topics. Mentor engineers on best practices.
Qualifications: Education - Bachelor's degree in Human Factors Engineering, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering, Cognitive Engineering, or related field.
Work Experience - Minimum 4 years of Human Factor Engineering experience.
Preferred Qualifications:- 7+ years of Human Factors Engineering experience in the medical device industry preferred.
- Extensive experience conducting formative and summative usability studies, including protocol and report generation.
- Experience conducting user research activities, such as task/workflow analysis, interviews, focus groups, surveys, and voice of customer activities, including contextual inquiry.
- Proficient in creating usability plans, summary reports, and use-related risk assessments.
- Experience with Design Validation, including planning, conducting simulated use studies, and documenting results.
- Strong knowledge of industry standards regarding human factors and usability (FDA guidance, AAMI HE 75, ISO 62366, IEC 60601-1-6, ISO 11607-1).
- Experience ensuring compliance with 21 CFR 820.30 Design Controls and ISO 14971 Risk Management.
- Experience conducting evaluations to meet aseptic presentation requirements per Section 7 of ISO 11607-1.
- 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:
$101,000.00 - $152,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
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.
