Sr Engineer Human Factors (Engineering)

Job Summary

This position is responsible for leading and conducting Human Factors/Usability activities to ensure medical devices (Class I and II) are safe and effective for use. This engineer will collaborate with design engineers and 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 misuse and/or use errors. This position will oversee the completion of Design Validation activities, including execution of Design Validation Simulated Use studies, to ensure devices meet user needs and intended uses. The engineer should be familiar with ISO 14971, ISO 62366, IEC 60601-1-6, AAMI HE75, and general Medical Device and Healthcare regulations (21 CFR 820 and ISO 13485).

Job Description

• Working with internal and external resources, lead and execute user research activities and usability studies (formative and summative) in support of all product development stages.
  • Planning, recruiting, and executing usability studies.
  • 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 on usability and design validation strategy. Author and review protocols and reports in support of product development activities, design control requirements, design validation, risk assessments, and regulatory filings (global).
• Collaborate with product design teams to establish user needs and use human factors considerations to optimize device design and mitigate risks related to misuse and/or use errors. Create use-related risk analysis documentation and implement control measures. 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 design teams.
• Create, review, and update internal and corporate procedures and templates to comply with the latest industry standards and regulations (ISO 14971, HE75, IEC 62366, IEC 60601, etc.).
• 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 groups to develop methods for and ensure completion of all Design Validation deliverables.
• Lead training workshops that focus on a variety of usability and human factors engineering subjects
• Select and collaborate with 3rd party HF firms as needed

Required Experience:

Education

• Bachelor's degree in Engineering or Science

Work Experience

• Minimum 4 years of Human Factor Engineering experience.

Preferred Qualifications:

• 7 years of medical device Human Factors Engineering experience preferred.
• Experience leading human factors activities for medical device development projects, including recommending improvements based on studies and analyses.
• Experience conducting formative and summative usability studies, including protocol and report generation.
• Experience conducting task/workflow analysis, interviews, focus groups, surveys, and voice of customer activities including contextual inquiry.
• Experience creating usability plans, assessments, and summary reports. Experience creating use-related risk assessments by conducting hazards analysis of use-related hazards.
• Experience with Design Validation including conducting Design Validation simulated use studies, planning for Design Validation activities, and documenting results.
• Experience with industry standards regarding medical device human factors and usability (FDA, HE 75, ISO 62366, IEC 60601, ISO 11607) in the medical device development process.
• Experience with ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management.
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
• Experience with conducting evaluations to meet aseptic presentation requirements per ISO 11607.
• 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 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.