Equipment Engineer

Responsibilities:

Lead the qualification of assembly equipment / processes and tooling for identified parts.

Follow all safety and current Good Manufacturing (cGMP) requirements within the plant

Should have strong experience in executing DOEs and development of semi-automated equipment's.

Develop and execute Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS).

Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for assembly equipment / fixtures.

Create, execute, and document all validation activities within the plant-based system.

Use Design of Experiments (DOE) to optimize critical process parameters of manufacturing systems.

Understand and conduct Process Stability / Control / Capability methods, etc. for process characterizations / manufacturing /equipment development.

Expertise in GD&T and drawing interpretation to challenge and direct effective communication to enable robust manufacturing and CTQ (Critical to Quality) parameters.

Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.

Development and Application of gauging techniques and subsequent Measurement System Analysis (GR&R).

Participate as a critical team member on project teams to start up new facilities, equipment, or processes.