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Principal Compliance Engineer

Location: Chelmsford, MA

Resuscitation

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.

 

Principal Compliance Engineers are responsible for leading and overseeing R&D efforts to ensure ZOLL's products comply with all currently applicable domestic and international safety/performance standards.

 

Responsibilities

 

  • Developing uniform testing plans and methodologies for verifying device compliance and documentation that facilitates standard agency review;
  • Conducting/overseeing product testing against applicable standards requirements and developing/maintaining formal reports to document compliance;
  • Working directly with product development teams to ensure that applicable standards requirements are understood and effectively addressed in each product's design and development process;
  • Identifying all safety/performance standards currently applicable to ZOLL's medical devices
  • Maintaining the library of currently applicable standards documents;
  • Interpreting those standards and determining the requirements they place on each product design;
  • Working directly with product development teams to ensure that applicable standards requirements are understood and effectively addressed in each product's design and development process;
  • Developing uniform testing plans and methodologies for verifying device compliance and documentation that facilitates standards agency review;
  • Conducting/overseeing product testing against applicable standards requirements and developing/maintaining formal reports to document compliance;
  • Identifying new standards or standards changes that will impact the design of existing products and communicating those requirements throughout R&D;
  • Championing the modification of existing products to ensure their continuing compliance with current and soon to become effective standards;
  • Managing the interface between R&D and outside compliance test/certification agencies.
  • Contributing to the identification, analysis and management of risks associated with new products under

Essential Functions:

  • 60% Works directly with product development teams to identify applicable standards, document requirements they impose on new and existing products, develop and execute design for compliance plans. Evaluate the compliance of proposed new or modified designs and manage the compliance testing process inside ZOLL and with 3rd party certification labs.
  • 20% acts as primary liaison between ZOLL and 3rd party testing/certification organizations to notify 3rd parties about product changes affecting standards compliance, arrange product testing or other efforts needed to maintain certification, review 3rd party test reports for continuing accuracy, notify development teams of compliance failures requiring remediation and maintain up­ to-date copies of all internal and 3rd party standards compliance and certification reports.
  • 10% provides performance and safety standards consulting to groups throughout ZOLL regarding standards requirements, efforts needed to maintain continuing compliance and follow-up auditing/testing by organizations who certify ZOLL's product compliance .
  • 10% maintains up to date knowledge of the domestic and international safety/performance standards applicable to ZOLL products and ZOLL's library of currently applicable standards documents.

Qualifications

  • Working knowledge of domestic and international regulations and standards applicable to medical electronic devices
  • Significant experience performing hand-on compliance testing of medical devices
  • significant experience directly interfacing with standards agencies
  • Project Management skills
  • Proficient in the use of standard office software productivity tools
  • Excellent interpersonal skills
  • Good verbal and written communication skills

 

Required/ Preferred Education and Experience:

  • Bachelor of Science in Electrical Engineering or equivalent.
  • 1O+ years Compliance Engineering experience
  • 5+ years' experience in domestic and international compliance of electronic medical devices

 

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V.