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New Product Development Engineer

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Onsite

New Product Development Engineer

Katalyst CRO

New Product Development Engineer

Skills

PythonRCompliance

1 month ago

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Important information


Contract type:

Freelance / Contract

Location:

Irvine, CA, USA

Work mode:

Onsite

Published on:

13 September 2026

What they need


  • 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.

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