R&D Test Engineer: Automated Medical Device Validation

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an R&D Test Engineer in Irvine to drive development, automation, and optimization of test methods for medical device components and prototype systems. You will build automated setups, fixtures, and scripts while collaborating with R&D, Quality, and Manufacturing teams to ensure robust product characterization and verification.

The role emphasizes data analysis, documentation, and scalable processes, with a focus on long-duration testing and high-precision manufacturing

Qualifications

• Bachelor's degree in Engineering or related technical discipline preferred.
• Experience in R&D testing, medical device testing, automation, or related engineering activities.
• Hands-on experience with test method development, automation scripting, instrumentation, or hardware setup preferred.
• Exposure to additive manufacturing, high-precision manufacturing systems, or prototyping tools is a plus.
• Experience with data analysis, technical documentation, and reporting.
• Strong problem-solving, multitasking, and communication skills.
• Ability to work effectively in a collaborative team environment.
• Proficiency in reading, writing, and speaking English required.

Responsibilities

• Develop, optimize, and automate test methods for characterization and verification of medical device components.
• Design and implement automated simulated-use test setups to improve throughput and enable long-duration testing cycles.
• Create test scripts, instrument control logic, and hardware automation solutions to streamline testing processes.
• Design, prototype, and refine 3D printed test fixtures for evaluation of early-stage prototypes and pre-clinical testing.
• Build and assemble sample components for device performance testing, feasibility studies, and characterization activities.
• Evaluate and optimize manufacturing printer settings, including high-precision and additive manufacturing systems, for production of high-density multi-electrode components.
• Conduct experiments to improve electrode impedance and signal-to-noise ratio (SNR) performance.
• Collaborate with Manufacturing Engineering teams to transition test findings into scalable production processes.
• Collect, analyze, and interpret test data; prepare technical summaries and communicate findings to cross-functional teams.
• Maintain detailed engineering documentation, test protocols, and technical reports.
• Effectively manage multiple assignments and prioritize tasks in a fast-paced environment.
• Follow complex written procedures and contribute to achieving overall team objectives.
• Perform additional duties and responsibilities as assigned.

Skills

R&D testing

Automation

Data analysis

Documentation

Multitasking

Communication

Education

Bachelor's degree in Engineering

Tools

Instrumentation

Automation scripting

Job description

Katalyst CRO is seeking an R&D Test Engineer in Irvine to drive development, automation, and optimization of test methods for medical device components and prototype systems. You will build automated setups, fixtures, and scripts while collaborating with R&D, Quality, and Manufacturing teams to ensure robust product characterization and verification.

The role emphasizes data analysis, documentation, and scalable processes, with a focus on long-duration testing and high-precision manufacturing