Senior Human Factors Engineer

Medline Industries, LP; United States; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP is seeking a Human Factors Engineer to lead HF activities across the product lifecycle, focusing on safe, effective medical device interfaces, packaging, labeling, and instructions for use. The role includes advising on design validation, conducting simulated use studies, and mentoring engineers to improve usability and reduce use errors.

The position requires a Bachelor's degree in a related field and a minimum of 4 years of HF Engineering experience.

Qualifications

• Bachelor's degree in a related field as listed.
• Minimum 4 years of Human Factor Engineering experience.
• Experience with formative and summative usability studies, including protocol and report generation.
• Strong knowledge of 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.

Responsibilities

• Lead Human Factors activities across the product lifecycle, from concept to post-market surveillance.
• Develop usability strategies and provide guidance to product development teams.
• Lead and execute usability studies with end users across all stages of development.
• Create and maintain usability engineering documentation (plans, summaries, risk analyses).
• Mentor engineers on best practices and lead process improvement initiatives.

Skills

Human Factors Engineering

Usability Engineering

Risk Assessments

User Research

Cross-functional Collaboration

Mentoring

Education

Bachelor’s degree in Human Factors Engineering, Usability Engineering, Cognitive/Experimental Psychology, Biomedical Engineering, Industrial Engineering

Job description

Job Summary

This 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.

Responsibilities

• 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).

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 .

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.

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.

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.