Product Development Engineer:
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.
- Design, development and tooling of new disposable electrodes and other specialty products and operate in compliance with (WESTAFF CLIENT) design control procedures.
- Development of new materials for use with disposable external defibrillation, pacing, monitoring, (ECG) and other specialty electrodes.
- 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.
- Performing all testing and recording of data in laboratory environment as required by a specific project on an as needed basis.
- Assist R&D Technicians as needed.
- Other duties as assigned.
Four-year degree in electrical/bio medical or related discipline.
Two to 4 years related experience.
Computer proficient in Word, Excel with experience using AutoCAD.
Ability to access and enter data into the Agile Software system
Working knowledge of Solid Works helpful.
Problem solving, analytical/investigative experience
Familiarity with the use of mechanical and electrical test equipment.
510K experience helpful.