Advisory Human Factors Engineer - Contract

Location: Remote, 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.

Job purpose

The Human Factors Engineer implements User centered design principles by conducting iterative user research and usability testing of medical device products and digital services prior to launch. In the role of user research, the HF engineer provides the R&D group with in-depth analysis of the user and existing product use. In the role of usability tester, the HF engineer ensures products and services are safe, easy to use, and easy to learn by analyzing risks, and developing and executing Human Factors testing. You are an integral part of the R&D project cross function team that represent the patient/user’s needs are considered throughout the entire product development process. Instill the benefits and value of the User centered design principle across the entire organization.

Duties and responsibilities

Primary job duties and responsibilities of the position.

  • Drive patient-focused product innovation by leading the development of human factors engineering processes within the organization, including the management of standard operating procedures.

  • Works closely with a cross-functional development team throughout a product development effort to ensure that user needs, usability requirements, and use errors are identified and addressed in the design process.

  • Lead analytic human factors activities (e.g., use FMEA, task analysis, heuristic evaluation) for the purposes of “design input,” risk assessment and mitigation, and protocol development

  • Lead the development and execution of formative and summative evaluations at various stages of product development from early prototypes through formal FDA-mandated validation

  • Work closely with development engineers and R&D Management to ensure the HF/UE process is followed through all phases of the system lifecycle.

  • Engage Quality and Regulatory to drive development of processes documentation to meet regulatory requirements

  • Collaborate with external Human Factor Engineering consultancies, internal stakeholders and partner organizations

  • Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills and abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

  • Educations and/or Experience:

B.S. or M.S. degree or equivalent industry experience in biomedical engineering, psychology, human factors, or a related discipline. Typically 10+ years of relevant experience. Proven track record performing the above Duties and Responsibilities. Understanding of Human Factors Usability Engineering process is required. Proven successful FDA submissions with human factors component is required.  Experience with Human Factors FDA Guidance, and IEC 62366, and management of HF usability file for a medical device is desired.

  • Language Skills:  Ability to read and interpret documents of advanced technical complexity.  Ability to write reports and research findings of a technical nature.  Ability to speak and present effectively one-on-one as well as in small and large groups of professionals including customers, clients and collaborators, both inside and outside the organization.

  • Mathematical Skills:  Basic mathematical skills required, including the understanding and ability to apply basic statistical and arithmetic principles, work with tabular data, and create and interpret graphs.

  • Reasoning Ability:  Advanced reasoning skills required.  Must have the ability to solve complex problems and weigh possible solutions to determine rank options to deliver optimal outcomes.  Ability to assess problems involving several variables in changing situations.

  • Computer Skills:  To perform this job successfully, an individual should be proficient in Microsoft Office Suite.

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.

The noise level in the work environment is usually quiet.

Physical requirements

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.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.  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

ZOLL now mandates COVID vaccinations subject to legal exemptions.

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