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Usability Engineering Manager

Usability Engineering Manager

Job ID 
2017-1056
Job Locations 
US-MA-Chelmsford
Category 
Research & Development
Type 
Full-Time/Regular

More information about this job

Overview

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:

Manager for the usability department, which encompasses overseeing and mentoring usability engineers, assignment tracking, technical direction and procedure/protocol/plan reviews. Responsible for overseeing the execution and maintenance of the usability engineering process to comply with the FDA and other regulatory bodies; including writing usability plans/protocols/test reports, recruiting participants, scheduling and leading both formative and summative testing, and managing use requirements across multiple projects.

Responsibilities

  • Grow the depth and breadth of ZOLL’s competency in Usability, Human Factors, and Ergonomics.
  • Advance the development of the Usability engineering team by acting as a mentor and leader for less experienced Usability engineers
  • Work closely with cross-functional development teams to ensure that user needs, usability requirements, and use errors are identified and addressed through all phases of the system lifecycle
  • Usability testing throughout the product development process, from formative testing of early prototypes through summative testing of final designs. Develop test plans and protocols, execute testing and write reports. Interact with customers and usability subjects to assess product usability and recommend design improvements to mitigate risks
  • Assess Usability issues for products that are out in the market including analyzing complaint and field data and determining when usability is required as products are updated
  • Develop collaborative working relationships with other functions within the product development organization such as design quality, regulatory, engineering design, clinical development engineering, and product marketing
  • Ensure the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies
  • Apply FDA human factors processes towards the development of medical devices and follow the guidelines of the FDA and other regulatory bodies (e.g. IEC 62366, IEC 60601-1-6, AAMI HE75).
  • Lead the Usability engineering staff and oversee outside consultants to effectively and efficiently support product development efforts within the company
  • Lead the team’s collaborative work with the regulatory group to develop strategies for new product submissions, process improvements, and responses to questions from regulatory agencies
  • Work with Project/Program management to establish and refine usability and human factors requirements for new and enhanced products
  • Key contributor to the system level risk management activities with assigned programs.

Qualifications

  • Extensive knowledge and understanding of the Human Factors Usability Engineering process
  • Experience with Human Factors FDA Guidance, IEC 62366, IEC 60601-1-6, and management of HF usability file for a medical device
  • Knowledge and experience developing products under FDA and European Community medical device regulations and standards or similar highly regulated industry
  • Demonstrated leadership on a Usability engineering team
  • Demonstrated success working in a cross-functional development organization
  • Excellent verbal and written communication, listening and observation skills. Must be comfortable interacting with customers/users on a regular basis.
  • Demonstrated success in technical decision making in a matrix environment
  • 8+ years of human factors and usability experiences in technology development (at least 5 years related to the medical device industry desired)
  • 3+ years of management experience

 

 

Education:

Bachelor's degree in Biomedical Engineering, Human Factors Engineering or other engineering (software, electrical, etc.) with medical concentration. Advanced degree is a plus

 

 

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