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Senior Product Development Engineer

Location: East Providence, RI

Resuscitation

Primary Purpose: 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

Competencies:

  • Four-year degree in Bio-medical/Electrical/Mechanical Engineering or related discipline.
  • 10+ years of related experience
  • Experience in medical device or other highly regulated industry experience preferred
  • Any similar combination of education and experience
  • 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.

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. 

 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990