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.

 

 

 

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records