USABILITY VALIDATION SPECIALIST Respiratory & Surgical Solutions (RSS) Business Unit
Verathon is seeking a Usability Validation Specialist to lead usability validation requirements for the Respiratory & Surgical Solutions (RSS) business unit, anchored by the GlideScope Video Laryngoscope. GlideScope assists anesthesiologists and emergency responders in hospitals and EMS around the world to achieve improved airway management outcomes: rapid first pass intubation success, lower risk of complications, and improved patient care.
The Usability Validation Specialist will help ensure our Respiratory & Surgical Solutions products are safe and easy to use. As part of the new product development process, you will have primary responsibility for creating usability risk analysis and conducting summative usability validation studies to test understanding of our products and labeling. The Usability Validation Specialist also works closely with the regulatory group to create the usability validation documentation required for submission to medical device regulatory agencies.
The Usability Validation Specialist reports to the Sustaining Engineering Manager for the RSS business, and will be based at either our headquarters in Bothell, WA or our R&D facility in Burnaby, Canada.
Manage usability validation activities; provide schedules and status to program managers.
Lead the efforts required to create and update usability risk analyses for RSS products.
Review and provide input to key use related documents and activities, including user needs, user requirements, formative product assessments, 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 and document regression analyses for legacy product design changes.
Prepare and review documentation for submission to regulatory agencies and notified bodies, including HFE/UE Reports. Answer questions and provide additional justification and rationale to any questions received.
Keep abreast 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) and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.
Knowledge, Skills, and Abilities:
BS/BA in related discipline
5 years of validation or 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 simultaneously - exceptional organizational and time management skills
Strong qualitative 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, self-directing, and strong attention to detail
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
Up to 10% domestic and foreign travel required
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 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, and has international subsidiaries in Canada, Europe and Asia. For more information, please visit www.verathon.com.
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, sex, national origin, age, disability, or any other characteristic protected by law build a strong foundation for success.