Test/NPI Engineer

Katalyst CRO; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is looking for a Test Engineer in Irvine, California, responsible for designing and implementing test solutions for manufacturing processes. You will develop automated test systems to improve quality and reliability during production. The ideal candidate holds a Bachelor’s degree in engineering, has at least 5 years of experience in test development, and is skilled in LabVIEW and Python. A strong understanding of verification best practices in the medical device industry is essential.

Qualifications

• Proficient in test method validation and analysis.
• Solid understanding of testing best practices.
• Hands-on experience with electronic measurement instruments.

Responsibilities

• Design and develop production test systems for verification.
• Implement automated test solutions to enhance production efficiency.
• Document all test procedures in line with quality management systems.

Skills

Problem-solving skills

Test method analysis

Documentation skills

Communication

Teamwork abilities

Education

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

5+ years of experience in test development or test engineering

Tools

LabVIEW

Python

Job description

Job Description

The ideal candidate will be responsible for designing, developing, implementing, and supporting test solutions for manufacturing and operational processes. This includes automated test systems, diagnostics, calibration and verification tools to ensure the quality and reliability of products during production.

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 systems.
• Perform Gauge R & R and IQ/OQ/PQ for custom test fixtures.
• Develop and perform design of experiments.

Required Skills & Abilities

• Strong problem‑solving skills and attention to detail.
• Proficient in test method analysis and test method validation.
• Good documentation skills with strong communication and teamwork abilities.
• Demonstrated ability to work on problems of a complex scope where analysis of situations or data involves multiple competing factors.
• Solid understanding of verification and testing best practices.

Education & Experience

• Bachelor's degree in mechanical engineering, biomedical engineering, or a related field.
• 5+ years of experience in test development or test engineering, preferably in a production or operations setting.
• Working knowledge in test software environments such as LabVIEW and/or Python preferred.
• Experience in executing verification/testing software in a design and production environment.
• Experience within a highly regulated medical device industry.
• Hands‑on experience with electronic measurement instruments (e.g., oscilloscopes, multimeters, power supplies).