Staff Human Factors Engineer

Location: Pittsburgh, PA, United States of America

Cardiac Management Solutions

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job Summary:

Works with team members to apply the usability engineering process to comply with the FDA and other regulatory bodies. This includes writing usability plans/protocols/test reports, recruiting participants, scheduling and participating in both formative and summative testing, and assisting with the management of use requirements across multiple projects.

Essential Functions:

  • 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. Assist with development of 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.
  • 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).
  • Work with the Usability engineering team and outside consultants to support product development efforts within the company.
  • Work with the usability team and 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.
  • Participate in the determination of use related hazards and the development of use risk analyses.
  • Some travel required.

Experience / Skill Requirements:

  • Knowledge and understanding of the Human Factors Usability Engineering process.
  • Knowledge and understanding of the 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.
  • Experience working in a cross-functional development organization.
  • Strong verbal and written communication, listening and observation skills. Must be comfortable interacting with customers/users on a regular basis.

Education Requirements:

  • Bachelor's degree in Biomedical Engineering, Human Factors Engineering or other engineering (software, electrical, etc.) with medical concentration. Advanced degree is a plus.
  • 1-5 years of human factors and usability experiences in technology development (at least 1 year related to the medical device industry desired).

Working conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position is generally performed in a typical office environment that is usually quiet.  Employee is expected to work collaboratively with team members, as well as able to work independently with limited supervision.  Work will require significant computer and telephone work.

Physical requirements

If the job is physically demanding, this should be stated in the job description. A physically demanding job is one where the incumbent is required to stand for extended periods of time, lift heavy objects on a regular basis, do repetitive tasks with few breaks, and so forth.

While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

Supervisory responsibility

None

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

 Equal Opportunity Employer – Disability and Veteran