New Product Test Engineer - Automated Test & Validation

Katalyst CRO; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO in Irvine, CA is seeking a Test Engineer to design, develop and support test solutions for manufacturing and operations, ensuring quality and reliability of products during production.

The role involves collaboration across design, quality, manufacturing and vendors to implement automated tests, fixtures and scripts, and to calibrate equipment in a highly regulated medical environment.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, or related field.
• 5+ years of experience in test development or test engineering in production/operations.
• Working knowledge of LabVIEW and/or Python preferred.
• Experience in a highly regulated medical device industry.
• Hands-on experience with electronic measurement instruments (oscilloscopes, multimeters, power supplies).

Responsibilities

• Design and develop production test systems (hardware and software) for product verification and validation.
• Collaborate with design, quality, manufacturing and vendors to define test requirements and ensure test coverage.
• Implement automated test solutions to improve efficiency, accuracy, and scalability in production environments.
• Develop and maintain test fixtures, scripts, and infrastructure.
• Provide technical support to manufacturing and operations teams to resolve test-related issues.
• Maintain and calibrate test equipment, ensuring compliance with industry standards and internal policies.
• Document all test procedures, specifications, and results in line with quality management system.
• Perform Gauge R & R and IQ/OQ/PQ for custom test fixtures.
• Develop and perform design of experiments.

Skills

LabVIEW

Python

Test development

Problem solving

Documentation

Teamwork

Education

Bachelor's degree in mechanical engineering, biomedical engineering, or related field

Tools

Oscilloscopes

Multimeters

Power supplies

Job description

Katalyst CRO in Irvine, CA is seeking a Test Engineer to design, develop and support test solutions for manufacturing and operations, ensuring quality and reliability of products during production.

The role involves collaboration across design, quality, manufacturing and vendors to implement automated tests, fixtures and scripts, and to calibrate equipment in a highly regulated medical environment.