Hybrid Manufacturing Engineer, GMP Med Devices (Irvine)

Fusion Energy Base; Irvine (CA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k) with match

Paid vacation & sick time

Holiday

Job summary

TAE Life Sciences in Irvine, CA is seeking a Manufacturing Engineer to develop and optimize production processes for GMP manufacturing, build and scale manufacturing capability, and provide technical support for production equipment.

You will collaborate with scientists and quality teams to ensure regulatory compliance under FDA and ISO 13485, perform process validation, and drive continuous improvement in equipment performance and documentation.

Qualifications

• Bachelor's degree or higher in a related engineering field is required.
• 5+ years of experience in thin film processes and related equipment.
• Experience in regulated environments (medical devices or equivalent) preferred.

Responsibilities

• Develops and optimizes production processes for manufacturing.
• Provides technical support for production equipment in a GMP environment.
• Builds and scales up manufacturing capability.
• Collaborates with scientists, design engineers, and quality teams to scale operations.
• Performs process validation, equipment, tooling, and process documentation under FDA and ISO 13485.

Skills

Thin film deposition

CVD

PVD

Thermal evaporation

GMP/Regulated environment

Education

Bachelor’s degree in Manufacturing, Materials, Chemical Engineering, or related field

Job description

TAE Life Sciences in Irvine, CA is seeking a Manufacturing Engineer to develop and optimize production processes for GMP manufacturing, build and scale manufacturing capability, and provide technical support for production equipment.

You will collaborate with scientists and quality teams to ensure regulatory compliance under FDA and ISO 13485, perform process validation, and drive continuous improvement in equipment performance and documentation.