Job Description

Skills, experience & qualifications required:

Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred. 5+ years in a quality or regulatory engineering role in the Medical Device field or highly regulated industry. Minimum 3+ years in a quality or regulatory role with focus on Software. Knowledge of and experience in IEC 62304 and experience with software design and validation for medical devices. Knowledge of the standards related to medical devices, including ISO 13485, 21 CFR Part 820 and ISO 14971. Understanding of design control, disciplined product development processes, regulatory, and quality requirements. ISO 13485 inspections and FDA inspections experience preferred.
Job Types: Full-time, Permanent

Benefits:

* Health insurance