Test/NPI Engineer

Katalyst CRO; Irvine (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

Katalyst CRO in Irvine, CA seeks a seasoned test engineer to design, develop, and support production test solutions for medical devices, ensuring reliability and regulatory compliance.

You will build test fixtures, automate processes with LabVIEW and Python, perform Gauge R&R and IQ/OQ/PQ, and document procedures in the quality system. A bachelor's degree in engineering and 5+ years in test development are required. Experience in a regulated medical device environment is preferred.

Qualifications

• Bachelor's degree in mechanical/biomedical engineering or related field.
• 5+ years of experience in test development or test engineering.
• Experience in regulated medical device industry.
• Hands-on experience with 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 systems.
• Perform Gauge R&R and IQ/OQ/PQ for custom test fixtures.
• Develop and perform design of experiments.

Skills

Test method analysis

Test method validation

Documentation

Communication

Teamwork

Problem solving

Education

Bachelor's in Mechanical Engineering

Biomedical Engineering

Related field

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.

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).