New Product Development Engineer

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

• 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.

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

Requirements:

• 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).

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.