B.S. or masters degree in science or engineering, or related disciplines
Minimum of three (3) years of related experience in medical device Quality or Design Assurance
Class III medical product development experience preferred
Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
Experience of statistics and a good working knowledge of test method validation.
Experience of preparing technical documentation
Excellent communication, organizational and time management skills
Availability to travel may be required