Usability Engineer II

ZOLL Medical Corporation•Chelmsford, MA

1d•$88,000 - $110,000

About The Position

At 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 As a Usability Engineer II, you will work with cross-functional teams to provide usability support for new products and product enhancements throughout the product development life cycle. This includes developing usability plans and protocols, use-related hazards analysis, planning and executing formative and summative usability testing and providing usability documentation for regulatory submissions and design history files. Key to your success will be your ability to communicate well with representative users, and to collaborate well with development teams

Requirements

BS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline (software, mechanical, etc.) preferred or MS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline (software, mechanical, etc.) preferred
2 + years of medical device usability engineering experience required and Practical experience applying IEC 62366, FDA Guidance, MDR, and HE75 in an end-to-end medical device development project required
Working knowledge of the FDA UE Process Guidance, IEC 62366, 60601-1-6, MDR, andHE75
Strong communication and writing skills. Must be comfortable interacting with customers/users, can communicate ideas effectively to internal stakeholders
Works with minimal supervision. Reports project, schedule and objective status
Collaborator and team player; works well with the Usability team and project teams

Nice To Haves

Experience with medical device simulation tools a plus

Responsibilities

Create usability documentation for design history files and tech files, including usability plans, use specifications, task analysis, use error analysis, usability assessments for feature modifications, usability audits, usability engineering files, and HFE/UE reports
Drive the early identification of use-related hazards and participate in use risk analysis
Work closely with cross-functional development teams to ensure that user needs, and potential use-related hazards are identified and addressed throughout the development lifecycle.
Develop test protocols, recruit participants, conduct usability testing, analyze test results and write formative and summative usability test reports
Conduct MAUDE searches and perform complaints analysis as needed
Keep pace with medical device national and international standards and guidance’s that have a usability engineering impact and understand how to apply them
Contribute to refining internal usability best-practices