Manufacturing Engineer

TAE Technologies•Irvine, CA

2d•Hybrid

About The Position

Develops and optimizes production processes for manufacturing. Provides technical support for production equipment in a GMP manufacturing environment. Building and scaling up manufacturing capability. Collaborate with scientists, design engineer, and quality teams to scale production operations. Responsible for process validation, equipment, tooling, and process documentation under FDA and ISO 13485 standards. Troubleshooting process deviation and implementing solutions to improve processes and consistency. Equipment maintenance support and ensure robust equipment performance, regulatory compliance, and continuous enhancement of production efficiency. Developing fixturing and tooling designs or concepts and collaborate with design engineers to implement ideas. Supporting new equipment acquisition efforts including machine selection, installation, validation, training, and other related equipment responsibilities as required. Supporting in development of documentations, SOPs, control processes, and practices. Must adhere to all relevant SOPs, work instructions, and company policies as part of TLS’s Quality Management System.

Requirements

Bachelor’s degree in manufacturing, Materials, Chemical Engineering, or a related field required.
A minimum of 5 years’ experience working in thin film process and equipment, such as CVD, PVD, particularly Thermal Evaporation process.

Nice To Haves

Experienced in a regulated environment, medical device or similar quality management system is preferred.

Responsibilities

Develops and optimizes production processes for manufacturing.
Provides technical support for production equipment in a GMP manufacturing environment.
Build and scale up manufacturing capability.
Collaborate with scientists, design engineer, and quality teams to scale production operations.
Responsible for process validation, equipment, tooling, and process documentation under FDA and ISO 13485 standards.
Troubleshoot process deviation and implement solutions to improve processes and consistency.
Provide equipment maintenance support and ensure robust equipment performance, regulatory compliance, and continuous enhancement of production efficiency.
Develop fixturing and tooling designs or concepts and collaborate with design engineers to implement ideas.
Support new equipment acquisition efforts including machine selection, installation, validation, training, and other related equipment responsibilities as required.
Support in development of documentations, SOPs, control processes, and practices.
Adhere to all relevant SOPs, work instructions, and company policies as part of TLS’s Quality Management System.