ZOLL MEDICAL — Manager of Human Factors and Usability Engineering

Location: Pittsburgh, PA

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.

Fueled by the success of the business, the ZOLL R&D team is growing rapidly. ZOLL’s ongoing investment in Research and Development aims to further increase the array of clinical products and applications in tandem with expanding the population of cardiac patients that may be helped by our products. Our Pittsburgh based R&D group is comprised of an exceptional team of talented, collaborative, and driven individuals focused on developing real world solutions through the creative and intelligent use of technology that helps to improve patient lives.

Job Purpose

This position will be responsible managing the Human Factors and Usability Engineering team. The Human Factors and Usability Engineering team is responsible for human-centered development throughout the entire life cycle of the various products for Cardiac Management Solutions. The manager of this team is also responsible for ensuring that usability processes and methodologies meet applicable regulatory requirements.

Duties and Responsibilities

  • Manage team of human factors engineering staff, outside consultants, and co-ops/interns. Drive recruitment, development, and retention of high performing individuals.
  • Appropriately staff product development projects, considering project scale and necessary HF skills and activities, to support effective and efficient product development efforts within the company.
  • Champion human-centered development best practices within an agile organization and develop collaborative working relationships with other functions within the organization, including regulatory, marketing, clinical, product management, and other functional disciplines within the research and development team.
  • 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.
  • Support testing throughout the product development process, from formative testing of early prototypes through summative validation of final designs.
  • Ensure the company’s usability engineering processes and methodologies meet and surpass the latest requirements and guidelines established by applicable regulatory agencies (FDA, EU notified bodies, etc.).
  • Apply FDA human factors processes towards the development of medical devices and follow the guidelines of the FDA, other regulatory bodies, and medical device organizations (e.g. IEC 62366, AAMI HE75).
  • Lead the team’s collaborative work with the regulatory department to develop strategies for new product submissions, product and process improvements, and responses to questions from regulatory agencies.
  • Stay current on state-of-the art Human Factors Engineering usability research and test methods.
  • Collaborate with other divisions of ZOLL to share and establish best practices

Qualifications

Qualifications include:

  • B.S., M.S., or Ph.D. degree in biomedical engineering, industrial systems engineering, cognitive/experimental psychology, or related field.
  • Minimum of 8 years of human factors and usability experiences with development of complex instrumentation/products (FDA Class II/III medical device experience desired).
  • Minimum of 5 years of managing a technical team.
  • Understanding of Human Factors Usability Engineering process.
  • Experience with Human Factors FDA Guidance, and IEC 62366, and management of HF usability file for a medical device is required.

Working Conditions

Typically, the work hours required for this position are weekdays during traditional business hours. Occasionally weekend or evening work may be require depending on project demands.

Physical Requirements

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk.

Supervisiory Responsibility

This position has supervisory responsibilities.

AAP/EEO Statement

ZOLL is an Equal Opportunity Employer – minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.

Recruiting Contact: Stan Caplan

scaplan@usabilityassociates.com,
(M) 585-478-7757