Manufacturing Engineer

Manufacturing Engineer

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.

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.

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 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 View email address on click.appcast.io to request accommodations or request more information.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.