Production Engineer

Job Responsibilities:

• Provide on-the-floor support for production lines, resolving mechanical and process issues that affect throughput or product quality.

• Implement process improvements that enhance efficiency, reduce cycle time, and minimize waste or scrap.

• Support new equipment introduction, qualification (IQ/OQ), and validation activities in collaboration with Engineering and QA.

• Author and revise work instructions, batch records, and training documentation to reflect process changes.

• Monitor OEE and other KPIs to identify bottlenecks and lead root cause investigations when performance drops.

Qualifications:

• B.S. in Mechanical, Industrial, or Biomedical Engineering.

• 2–5 years of experience in manufacturing engineering within a GMP or ISO 13485 environment.

• Strong understanding of FDA regulations, lean manufacturing principles, and troubleshooting methods.

• Hands-on experience with packaging equipment, conveyors, automated filling systems, or assembly lines preferred.