Reading Metro Area, PA
Support multiple facility projects including validating a new cannula supplier, validating the new coined blade process, and validate new automation equipment as needed. Candidate will also provide engineering technical support for testing, trouble shooting, and protocol execution. Additional duties will include creating engineering drawings and making process improvements as required.
Duties Include to following activities under the guidance of the project manager and / or the engineering manager.
- Create Creo, Pro-E 3-D models and 2-D drawings following the Guidelines of the current engineering SOP s
- Assist the Technical Writer in identifying appropriate dimensional and mechanical features to be included in validation protocols.
- Assist in the execution of validation protocols for new components and related processes as required.
- Perform process improvements when applicable and follow-up with necessary changes to Standard Operating Procedures.
- Under the direction of a Sr. Engineer or Project manager and using measuring equipment, perform testing and measuring activities Identified and described in validation protocols.
- Proficient in use of Creo, Pro-E modeling software
- Good communication skills
- Ability to work in a GMP medical device / controlled environment
- Good organization skills
- Statistical analysis experience is a benefit but not required
- Experience working in a GMP Medical Device Environment
- Experience writing and executing validation protocols is a benefit
- Experience working in a clean room environment is a benefit