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Human Factors Engineer III - Bothell, United States - Verathon
Description
Human Factors Engineer IIILocation
US-Bothell
ID
Category
Engineering
Position Type
Full-Time
Work Model
Onsite
Company Overview
Verathon
is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility.
Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management.
The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients.
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.
For more information, please visitOverview
Verathon
is seeking a Human Factors Engineer become the newest member of our Visualization Business Unit R&D Team in Bothell, WA.
As part of the new product development process, you will have primary responsibility for formative and summative usability studies to test understanding of our products and labeling.
The Human Factors Engineer will work closely with product planning to test product concepts and feed this information back to the design teams to optimize use of our products.
This person will also work closely with the quality and regulatory groups to create the usability and Human Factors documentation required for submission to medical device regulatory agencies.
ResponsibilitiesParticipate and provide usability input during the initial product concept design process.
Create the user requirements and specification documents.
Create use and human factors plans and protocols
Conduct formative usability research and create appropriate documentation to inform needed design changes
Participate in efforts required to create and update usability risk analyses for VBU products.
Provide input to key use related documents and activities, including user needs, product labeling, and the system risk assessment.
Create plans and protocols to validate indications for use, user needs, usability risk mitigations, labeling, and product claims
Conduct summative usability validation studies, including ultimate responsibility for user recruiting and testing
Write usability validation reports
Support content transfer into summary V&V and Safety Risk Management reports
Perform document regression analyses for legacy product design changes
Prepare documentation for submission to regulatory agencies and notified bodies, including HFE/UE Reports
Maintain current knowledge of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
Conduct post-use usability testing, providing input to NPD and sustaining project prioritization.
Advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.
Qualifications
Bachelor's degree in relevant field; Master's preferred.
Typically, a minimum of 5 years of human factors experience, Medical device experience is desired.
Familiarity with Use and Human Factors standards and regulatory guidelines regarding proper validation procedures
Ability to work on multiple projects at the same time - exceptional organizational and time management skills
Strong use and human factors research skills
Ability to analyze and synthesize large quantities of information
Superior ability to write accurate, clear, and concise protocols and reports in a timely manner
Excellent problem-solving skills
Self-motivated and strong attention to detail
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
10% domestic and foreign travel is required
EIT highly preferred
EEO
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities.
Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.
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