SENIOR HUMAN FACTORS ENGINEER – Respiratory & Surgical Solutions (RSS) Business Unit
Verathon is seeking a Senior Human Factors Engineer to lead usability research and human factors design initiatives 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.
Verathon understands that it’s a new world. The landscape of healthcare has shifted dramatically, and the effects across the care ecosystem are profound. So are the opportunities. As hospitals face increasing pressure to deliver better economic outcomes while they strive to improve patient care, Verathon is ready. With the right solutions—enduring solutions, backed by exceptional service from the industry leader, and engineered to meet the very different, very real needs of doctors, nurses, biomeds, and administrators. Solutions are chosen because of how they perform when it truly matters, helping healthcare providers make a real impact.
Your Role: This Senior Human Factors Engineer 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 formative and summative usability studies to test understanding of our products and labeling. The Senior Human Factors Engineer will work closely with the product planning to test product concepts and feed this information back to the design team 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.
The Senior Human Factors Engineer reports to the Director of Product Management for the RSS business, and will be based at our headquarters in Bothell, WA.
- 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
- 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, 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.
We are looking for an experienced individual with the following:
- 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, 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
* Must be willing to live and work in the Bothell, WA (Greater Seattle) area.
Education & Experience:
– BS/BA in related discipline
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.