Senior Product Development Engineer

Location: East Providence, RI, United States of America

Resuscitation

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.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Primary Purposes:    To develop new product designs, materials, and manufacturing techniques for defibrillation, monitoring and pacing, (ECG) electrodes and other specialty products. Provide engineering support to Production Department and Customer Service on existing products.

Primary Functions:

  • Design, development and tooling of new disposable electrodes and other specialty products in compliance with Bio-Detek design control procedures.
  • Develop specifications of new materials for use with disposable external defibrillation, pacing, monitoring, (ECG) and other specialty electrodes.
  • Assist Regulatory in preparation of 510K submissions to FDA relating to new or revised designs including required validation studies.
  • Support the Production Dept. in resolving manufacturing problems. Participate in investigation of and resolution of field incidents, customer complaints and other quality issues requiring technical support.
  • Assist in preparation of in-house specifications and documentation for new or revised designs consistent with FDA or ISO requirements.
  • Perform all testing and recording of data in laboratory environment as required by a specific project on an as needed basis.
  • Supervise R & D Technicians and Lab.
  • Lead projects as assigned and provide technical leadership to engineering team.
  • May have direct reports

Preferred/Required Skills:

  • Four-year degree in Biomedical/Electrical/Mechanical Engineering or related discipline.
  • 10+ years of related experience
  • Any similar combination of education and experience
  • Experience in medical device or other highly regulated industry experience preferred
  • Computer proficient (Word, Excel and 3D CAD).
  • Familiarity with the use of mechanical and electrical test equipment.
  • Analytical, investigative, and problem solving skills required.
  • 510K experience helpful.

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