Linac Development Engineer

ViewRay Systems, Inc.; Milpitas (CA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Paid time off

Job summary

A leading medical technology company in Milpitas, CA seeks a Linac Development Engineer. This full-time role includes developing innovative cancer therapy systems and ensuring compliance with FDA regulations. Candidates should have over 10 years of R&D experience, particularly with linear accelerators and relevant regulatory processes. The position offers health insurance and paid time off, supporting a collaborative environment dedicated to improving patient outcomes.

Qualifications

• 10+ years direct experience with R&D, prototyping, production and operations of medical FDA regulated systems.
• 5 years of experience with linear accelerator-based radiation systems and ancillary systems.
• Significant experience with IEC compliance requirements for medical linear accelerator systems.
• Significant IEC60601-2-1 and 60601-2-68 safety/compliance experience; EMC knowledge a plus.
• 5 years of cross-functional engineering in regulated medical environments.
• 5 years in acquisition and development of capital equipment for linear accelerator manufacturing.

Responsibilities

• Support development and documentation of medical linear accelerator-based products.
• Provide support for FDA/IEC regulatory processes.
• Document and provide results and improvements to appropriate groups.

Skills

R&D experience

Linear accelerator systems

FDA compliance

Cross-functional engineering

Software proficiency

Education

BS or higher in EE, ME or RF Engineering

Tools

LabView

Job description

ViewRay Systems, Inc. is a private technology company seeking to provide the global radiation therapy community with advanced medical instruments incorporating the highest level of technology possible. Our belief is that only significant technological innovation can enable society to conquer disease. Our mission is to dare to change the paradigms of medicine and solve “impossible” technical problems to enable clinicians to effect a cure to save precious human lives, mitigate pain and suffering, and enhance quality of life. Our vision is to become the world’s leader in producing highly effective innovative technology to cure cancer.

ViewRay Systems designs, manufactures, and markets the MRIdian A3i® radiation therapy system to treat cancer patients with the smallest radiation therapy margins available with the highest patient throughput demonstrated for the most complicated cases. The system treats by aligning the sharpest radiation therapy beam on the market to diagnostic quality magnetic resonance images (MRIs) of the patient, adapts the treatment plan to the reality of the patient, and then uses the real-time MRIs to control the beam and record real-time doses delivered to the patient.

Job Description

ViewRay Systems is currently seeking a Linac Development Engineer, who will share our passion for conquering cancer and help us develop systems novel cancer therapy systems.

Responsibilities

• Support development and documentation of medical linear accelerator-based products.
• Provide support for FDA/IEC regulatory processes required for stages from R&D to production, including V&V and lifecycle testing.
• Operate and support medical linear accelerator components and entire systems to produce desired high voltage operation and radiation production and measurement.
• Document and provide results and improvements to appropriate groups.
• Support BOM management to ensure DHR/DHF compliance in an FDA regulated environment.
• Managing Engineering Change Order operations from initiation to completion.
• Interface with project management to ensure all tasks are clearly defined, understood, supplied and managed properly.
• Assist with identifying and acquiring equipment, parts, tools and materials needed to ensure project success. Ability to facilitate operations to ensure optimum project progress.
• Support capital equipment acquisition for linear accelerators and ancillary systems.
• Understand the equipment and processes utilized in the management, production and operation of existing and new products.
• Provide input for improvements including risk mitigation, root-cause failure analysis and reliability improvements. Provide this to appropriate groups such as Field Service.
• Actively work to improve safety, performance, efficiency and down cost products and processes.

Required Qualifications

• 10+ years direct experience with R&D, prototyping, production and operations of medical FDA regulated systems.
• 5 years of experience with linear accelerator-based radiation systems and ancillary systems such as RF magnetron systems, cooling systems, RF waveguide assemblies, HV modulators, control systems and subsystems such as MLCs.
• Some operational experience with basic and medical dosimetry.
• Significant experience with IEC compliance requirements for medical linear accelerator systems according to IEC60601-2-1 and 60601-2-68. Experience with the general safety and EMC according to 60601-1, 60601-1-2 is desirable.
• 5 years of direct experience with cross‑functional engineering groups in regulated medical environments.
• 5 years of experience in acquisition and development of capital equipment for linear accelerator manufacturing, operations and support.
• Proficiency in software that is necessary for documentation, compliance and testing.
• Direct experience utilizing LabView for prototype medical device testing.
• BS or higher in EE, ME or RF Engineering.

Valued Qualifications

• 5+ years of experience with supplier controls and contracts

Job Type

Full‑time

Work Location

In person in Milpitas, CA

• Health insurance
• Vision insurance
• Paid time off

ViewRay Systems, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, creed, national origin, gender, age, sexual orientation, status as a protected disabled or Vietnam Era Veteran, disability, or any other legally protected status.

Reference

https://jamanetwork.com/journals/jamaoncology/fullarticle/2800541

[i] Kishan AU, Ma TM, Lamb JM, et al. Magnetic Resonance Imaging–Guided vs Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023;9(3):365–373. doi:10.1001/jamaoncol.2022.6558

[ii] Claudio Votta, et al., Evaluation of clinical parallel workflow in online adaptive MR‑guided Radiotherapy: A detailed assessment of treatment session times, Technical Innovations & Patient Support in Radiation Oncology, Volume 29, 2024, 100239. doi:10.1016/j.tipsro.2024.100239