Senior Test & NPI Engineer - Medical Devices

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

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.