Senior Usability Engineer
About The Position
Acute Care TechnologyAt ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! Job Summary Senior Usability Engineer provides human factors and usability engineering leadership on a variety of new product development and enhancement projects in the Resuscitation division. Activities include understanding users, developing usability plans and protocols, performing use-related hazards analysis, participating in design and making recommendations, executing formative and summative studies and providing usability support for regulatory submissions. Communicates effectively and works well with teams. Occasional travel required.
Requirements
- BS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline preferred (software, mechanical, etc.) preferred or MS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline preferred (software, mechanical, etc.) preferred
- 5+ years of work experience with at least 4 years in Usability Engineering in medical devices required and
- Practical experience applying IEC 62366, 60601-1-6, FDA Guidance for applying HF and UE to Medical Devices, and MDR to medical device design and development required
- Working knowledge of IEC 62366, 60601-1-6, FDA Usability Engineering guidance, MDR, and HE75
- Strong communication and writing skills. Must be comfortable interacting with customers and representative users. Communicates effectively with internal stakeholders and communicates status to manager in a timely manner
- Able to lead multiple projects; self-motivated and works with minimal supervision
- Works well with the Usability team and the project teams, collaborator and team player
Nice To Haves
- Experience developing prototypes with software simulation tools a plus
Responsibilities
- Usability lead on multiple programs, responsible for planning, managing and executing timely deliverables with minimal supervision
- Communicate effectively with project team, users, and vendors
- Author documents for design history files including usability plans, use specifications, usability evaluations of modifications, task analysis, use error analysis, usability assessments, complaints analysis for remediation of legacy products, test reports, and usability engineering files. When you are the usability lead on a project, you coordinate the work of other usability resources on the project
- Peer-review other usability team members’ documents
- Work closely with cross-functional development teams to ensure that user needs, and usability issues are identified and addressed
- Drive the early identification of use-related hazards
- Develop test protocols, coordinate with external research facilities to recruit participants and manage invoices, conduct usability testing, lead the root-cause analysis when analyzing the test results, and author test reports
- Conduct MAUDE searches for known use problems
- Perform complaints analysis and author usability documentation for the remediation of legacy devices/accessories
- Keep pace with Human Factors national and international Usability Engineering guidance’s. Understand how to apply these guidance’s and contribute to template development.
- Mentor less senior members of the Usability team
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
