Reading Metro Area, PA
- Work Experience in the engineering field as it relates to medical device manufacturing can be considered equivalent to a Bachelor's Degree in engineering.
Must have experience with the current version of Creo / Pro-E software.
- Proficient in the use of Pro-E modeling software Good communicaiton skills Ability to work in a GMP medical environment including working in a controlled environment room Good organizational skills Experience writing and executing validation protocols Working knowledge of statistical analysis is a benefit but not required.
- Support projects, including validation of a new cannula supplier, validating a new high speed coining process for blades and cutting instruments and automation equipment as needed.
- Will also provide engineering technical support for testing, trouble shooting, and protocol execution.
- Additional duties will include engineering design/drawing and process improvements.
- Duties will include the following activities under the guidance of the project manager and or the engineering manager. Create Pro-E models and 2-D drawings following the guidelines of teh current engineering SOP's Assist the technical writer to identify appropriate dimensional and mechanical features to be included in validation protocols Assist in the execution of protocols of blades cutting instruments and components Perform process improvements when necessary, and follow-up with any documentation changes resulting from the change.