Job Summary
This position is responsible for leading and conducting Human Factor/Usability activities to ensure medical devices (Class I and II) are safe to 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. 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
Responsibilities:
Working with internal and external resources, lead and execute user research activities (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 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 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 training workshops that focus on a variety of usability and human factors engineering subjects.
Conduct Design Validation simulated use studies to support Design Validation efforts.
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.
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 creating usability plans, assessments, and summary reports. Experience creating use-related risk assessments by conducting hazards analysis of use-related hazards.
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 medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
Experience conducting Design Validation simulated use studies and planning for Design Validation activities.
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).
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
