Manufacturing Engineer - GMP Thin Film & Process Scaling

Physics World; Irvine (CA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Paid vacation + sick time

Company holiday

Job summary

TAE Life Sciences, Irvine-based, is seeking a Manufacturing Engineer to build and scale manufacturing capabilities in a hybrid environment. You will collaborate with scientists, design engineers, and quality teams to scale production, validate processes, and maintain equipment per GMP and ISO 13485 standards.

The role requires a B.S. in manufacturing-related field and 5+ years in thin film processing (CVD/PVD/Thermal Evaporation); experience in regulated medical devices is preferred.

Qualifications

• Bachelor's degree in manufacturing, Materials, Chemical Engineering, or a related field required.
• At least 5 years' experience in thin film processes/equipment (CVD/PVD/Thermal Evaporation).
• Experience in regulated medical device or quality management systems preferred.
• Core hours 8am-5pm; hybrid role in Irvine, CA.

Responsibilities

• Plan and execute process validation, equipment, tooling, and process documentation under FDA/ISO 13485.
• Troubleshoot deviations and implement improvements for consistency.
• Maintain equipment performance and regulatory compliance; enhance production efficiency.
• Develop fixturing and tooling concepts; collaborate with design engineers.
• Support equipment acquisition, installation, validation, training, and related tasks.
• Develop SOPs, control processes, and practices; ensure QMS adherence.

Skills

Thin film process experience

Regulated environment experience

Problem solving

Collaboration with cross-functional

Education

Bachelor's degree in manufacturing, Materials, Chemical Engineering, or related field

Tools

CVD

PVD

Thermal Evaporation

GMP/ISO 13485 documentation

Job description

TAE Life Sciences, Irvine-based, is seeking a Manufacturing Engineer to build and scale manufacturing capabilities in a hybrid environment. You will collaborate with scientists, design engineers, and quality teams to scale production, validate processes, and maintain equipment per GMP and ISO 13485 standards.

The role requires a B.S. in manufacturing-related field and 5+ years in thin film processing (CVD/PVD/Thermal Evaporation); experience in regulated medical devices is preferred.