Job description
Location: East Providence, RI, United States of America
Resuscitation
Job Summary: 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.
Job Type:
Essential Job 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 specification 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.
Required/ Preferred Education and Experience:
- Four-year degree in Electrical/Bio-medical or related discipline.
- 5+ years related experience.
- Any similar combination of education and experience
Knowledge, Skills, and Abilities:
- Computer proficient (Word, Excel and 3D CAD).
- Analytical, investigative, and problem-solving skills required
- Familiarity with the use of mechanical and electrical test equipment.
- 510K experience helpful.
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