Senior Usability Engineer

Location: Chelmsford, MA

Resuscitation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Job Summary:

As a Senior Usability Engineer in the Chelmsford MA R&D department, you will have an opportunity to provide human factors and usability engineering leadership on a variety of new product development and enhancement projects in the Resuscitation division. You will be part of a growing usability team whose 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. Key to your success will be your ability to communicate effectively and to work well with teams. Occasional travel required.

Essential Functions:

  • You will be a 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 guidances. Understand how to apply these guidances and contribute to template development.

  • Mentor less senior members of the Usability team

Skills Requirements:

  • 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

  • Experience developing prototypes with software simulation tools a plus

Required/Preferred Education and Experience:

  • BS or MS in Human Factors Engineering, Biomedical Engineering, or other engineering discipline preferred (software, mechanical, etc.)

  • 5+ years of work experience with at least 4 years in Usability Engineering in medical devices

  • 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

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990