Remote Design Quality Engineer II Job in Kennesaw, GA Artivion, Inc.

Who you are

• Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
• Minimum of 3 years hands-on experience preferably in a FDA regulatory industry
• Specific experience in medical device Design Controls for developing and preparing design specifications
• Specific experience designing, preparing, executing, and statistically analyzing validations and developing report packages
• Specific experience in the application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical
• Personal computer skills, i.e., word processing, spreadsheets, data analysis

Desirables

• Risk Management Experience
• ASQ, CQE and CQA certifications

What the job involves

• Provide Design Quality Engineering support for NPD and serve on Technical Teams for Aortic programs in design control
• Support regional expansion and bring CE Marked implantable products into the US
• Develop, conduct, and document qualifications/validations to ensure products are reliable, safe, and effective prior to release