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Advisory Compliance Engineer

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.

Job purpose

Advisory Engineer responsible for a lead role in the development, support, and execution of test protocols that ensure system designs meet all applicable compliance (EMC, RF, Medical, and Safety) requirements.  Monitor compliance requirements as new versions or changes are released and update design documentation and testing accordingly. Interface with regulatory agencies in support of compliance efforts across product lines as required.  Additional responsibilities include ensuring the maintenance of compliance documentation and providing the lead compliance interface to management and other stakeholders within the organization.

Duties and responsibilities

  • Responsible for staying abreast of changes in the regulatory landscape that affect the business and driving the changes to ensure ongoing compliance of system designs.
  • Responsible for developing and executing test protocols that ensures hardware designs meet all applicable compliance (Environmental, EMC, RF, Safety) requirements.
  • Works closely with development engineers to define test protocols for Environmental, EMC, RF, and Safety verification / validation testing.
  • Responsible for the management and execution of compliance focused test activities.
  • Responsible for report generation of all compliance test activities.    
  • Interfaces closely with regulatory engineers and coordinates release activities and interactions with regulatory agencies. 
  • Produce documentation to prove product compliance with agency requirements across multiple countries and trace said requirements to test protocols and reports.
  • Adheres to product build, submittal, and release schedules and strategies.
  • Performs other duties as assigned by Management.

Qualifications

Requires B.S. degree in an electrical engineering or equivalent and a minimum of 13 years of relevant experience.  An advanced degree in electrical engineering or equivalent is preferred. Experience working with Agency safety standards, Hands on test execution and report generation, Test protocol development, 3rd party test coordination, Test fixture development are required. Experience working with IEC 60601, EMC test execution and lab coordination, certified body test coordination, and Medical device safety testing are preferred.

Working conditions

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 work.

Physical requirements

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

There are no supervisory requirements

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

 

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