Manufacturing Engineer

Job Summary

Perform compliance reviews on systems with FDA-related issues. Contribute to FDA audit response mitigation activities (12-month assignment). Involve in some software development work (Java preferred; other programming languages may be considered).

Education Requirements

• Minimum: Bachelor's or Master's degree in Electronics Engineering, Computer Science, Data, Manufacturing Engineering, or a related field.
• PREFERRED: Master's degree in Computer Science, Data Engineering, Mechanical Engineering, Electronics Engineering, or Manufacturing Engineering.

Experience Requirements

• Minimum: 2+ years of experience with a Bachelor's degree in Manufacturing/Operations, Engineering, Systems, Production Engineering, Computer Science, or Cost Engineering.
• PREFERRED: 1–3 years of experience with a Master's degree in a related field.

Preferred Skills

• Mechanical Engineering.
• SAP-ME and SAP ERP experience.
• ABAP skills with knowledge of SAP PM, IDocs, and RFCs.
• Java (SAP ME SDK), with exposure to MII transactions and XML/XSLT.
• Python or C# development, with APIs/web services and SAP NetWeaver RFC SDK.
• Microsoft Azure/Databricks.
• Product Lifecycle Management (PLM).
• Process improvements and lean manufacturing.
• Business acumen.
• Six Sigma and CAPA methodologies.
• Project management.
• Regulatory compliance knowledge.