Manufacturing Engineer

TAE Technologies, Inc; Irvine (CA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) with company match

Paid vacation + sick time

Companywide December holiday

Wellness program

Parental leave

Job summary

TAE Life Sciences (TLS) is seeking a Manufacturing Engineer to develop and optimize production processes in a GMP manufacturing environment. You will provide technical support for production equipment and ensure robust performance while adhering to quality standards.

Responsibilities include process validation, equipment maintenance, and collaboration with design engineers on fixturing. Hybrid role based in Irvine, CA, with a compensation range of $110,000–$140,000 annually and comprehensive

Qualifications

• 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.
• Experienced in a regulated environment, medical device or similar quality management system is preferred.
• Core hours are 8am-5pm, role is hybrid based in Irvine, CA.

Responsibilities

• 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.

Skills

GMP experience

Process validation

Education

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

Tools

CVD

PVD

Thermal Evaporation

Job description

TAE Life Sciences (TLS) is a biologically targeted radiation therapy company focused on developing novel treatment to improve the lives of patients with difficult-to-treat cancers. TLS has developed breakthrough technology for the clinical investigation of Boron Neutron Capture Therapy (BNCT) to provide a treatment option for patients with malignancies that are difficult to treat through traditional methods, such as head, neck and brain cancers. Our proprietary accelerator-based BNCT platform combines two well-known modalities - biological targeting and radiation therapy - for precision treatment at the cellular level.

The Manufacturing Engineer Develops and optimizes production processes for manufacturing. Provides technical support for production equipment in a GMP manufacturing environment.

About The Role

• 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.

About You

• 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.
• Experienced in a regulated environment, medical device or similar quality management system is preferred.
• Core hours are 8am-5pm, role is hybrid based in Irvine, CA.

At TLS, we consider a wide range of factors when making compensation decisions including but not limited to skill sets; experience and job-related knowledge, training; licenses and certifications, and other business and organizational needs. The total compensation package for this position may also include other elements, discretionary annual incentive bonus, depending on the position offered (non-Sr., Sr.). The compensation range for these roles are $110,000 - $140,000 annual salary.

We are a diverse team of over 500 engineers, scientists, professionals, Maxwell Prize winners, and big thinkers from more than 40 countries with a track record of delivering on the innovative ways science can lead humanity into a brighter era. We are not afraid to envision a future where fusion and science can transform our world.

What you’ll get with us

• Generous benefits such as Medical, Dental, Vision, 401 (K) with company match, paid vacation + sick time, companywide December holiday, wellness program, parental leave
• A collaborative environment: An organization where talents and interests can plug in to different groups throughout the organization
• HQ in Southern California
• A commitment to upholding and growing an inclusive organization

TAE Technologies is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. We ensure all individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us [e-mail] to request accommodations or request more information.