Minneapolis Area Medical Device Company is seeking a Sr. Manufacturing Engineer, experience supporting operations with demonstrated success in continuously improving operational performance, plus experience with support of CAPA and PQ activities. Previous experience working in an FDA regulated environment helpful.
Responsibilities for the Manufacturing Engineer
Requirements for the Manufacturing Engineer
- Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
- Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
- Completes and manages complex Capital Equipment Request Authorizations (CERA's)
- Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
- Writes validation protocols and reports applicable to new processes.
- B.S. degree in Engineering with 5 to 8 years' experience - M.S. degree in Engineering with 3 to 6 years' experience - PhD degree in Engineering with 0 to 3 years' experience
- Preferred experience in FDA regulated industry supporting operations with demonstrated success in continuously improving operational performance.
- Demonstrated support of CAPA and PQ activities.