Role: Senior Test/NPI Engineer

Location: Irvine, CA

Onsite Position

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).