Job Description
Manufacturing Engineer II | Contract- 12 months | Medical Device Industry | Maple Grove | $31-$50/HR
Job Description:
* Ability to follow the BSC applicable SOPs & WIs developed from EU MDR requirements
* Experience in creation or review of Risk Management deliverables
* Experience in all aspects of Process Validation - planning, writing protocols, executing, and writing reports
* Knowledgeable in Test Method Validation (variable and attribute) - planning, writing protocols, executing, and writing reports
* Ability to investigate/troubleshoot process and product as related to validation executions
* Understanding gap analysis on existing validations to current requirements for EU MDR submission
QUALIFICATIONS:
* Bachelor's Degree in Engineering (Mechanical, Biomedical, Chemical, Manufacturing, Industrial)
* 3-5 years' (minimum) experience in a manufacturing environment
* Medical device or regulated industry experience
Education/Experience/Skills that are not required, but helpful:
* Windchill