Senior Usability Engineer

Reposted Yesterday
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Chelmsford, MA, USA
In-Office
106K-133K Annually
Senior level
Healthtech • Software
The Role
Lead usability and human factors activities for medical device product development: develop usability plans, perform use-related hazard and task analyses, run formative and summative studies, author usability documentation for regulatory submissions, coordinate usability resources, mentor junior staff, and support remediation of legacy devices.
Summary Generated by Built In
Acute Care Technology

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
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.
Essential Functions

  • 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

Required/Preferred Education and Experience

  • 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

Knowledge, Skills and Abilities

  • 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

Travel Requirements

  • 20% Travel required

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Standing - Occasionally
  • Walking - Occasionally
  • Sitting - Constantly
  • Talking - Occasionally
  • Hearing - Occasionally
  • Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The annual salary for this position is:

$106,000.00 to $133,000.00

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

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

Top Skills

Fda Usability Engineering Guidance
He75
Iec 60601-1-6
Iec 62366
Maude
Mdr
Software Simulation Tools
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The Company
HQ: Chelmsford, MA
30,000 Employees

What We Do

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.

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