Electrical Engineer
Hicksville, NY
Full Time
Experienced
Job description
Seeking a motivated, intelligent, hard-working individual to grow as part of the Quality Assurance and Regulatory Affairs team.
PRIMARY DUTIES AND RESPONSIBILITIES
- Develop/design effective test methods.
- Facilitate software design and development for medical devices.
- Performance testing and reporting on software, hardware, and the compatibility for all accessories.
- Maintain/calibrate the accuracy of all testing equipment.
- Perform risk assessments for medical devices and accessories.
- Maintain the effectiveness of quality control system and non-conforming materials control system.
- Discuss and solve quality problems with vendors.
- Development and prototyping of new products with existing or new vendors.
- Investigate problems and make improvement on current products
- New product development.
REQUIREMENTS
Education : Bachelor degree in mechanical, electrical, material, biomedical engineering, or relative field.
Training : SOPs, Risk Assessment/ On-the-job Training
Abilities :
- Familiar with FDA 21CFR 820 and ISO 13485 regulations
- Knowledge of European regulations is a plus
- Extreme attention to details
- Knowledge of common medical materials (silicone, polyurethane, etc.)
- Knowledge of electrical circuits
- Knowledge of basic programming
- Able to think outside the box with excellent problem solving abilities
- Excellent interpersonal, commutation, and writing skills
- Highly organized
- Excellent computational skills (MS Office, databases, testing)
- Knowledge of C/C++ is a plus.
Experience : 2-5 years of experience as a quality representative in a FDA or ISO 13485 compliant company
Medical
Dental
401K
Vacation
Job Type: Full-time
Pay: $65,000 - $70,000 per year
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