Requirements:
Bachelor's Degree in Mechanical Engineering or equivalent.
10+ years medical device manufacturing industry experience.
Master's degree in Engineering with 8+ years industry experience.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
Domestic and international travel will be required
Knowledgeable of and works within FDA, MDR, ISO, IEC 60601, and other relevant regulations and standards.
Proficient with root cause analysis and corrective/preventive action procedures.
Proficient with statistics.