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New Product Development Engineer

Katalyst Healthcares & Life Sciences

Irvine, CA

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JOB DETAILS
SKILLS
Analysis Skills, Best Practices, Biomedical Engineering, Calibration, Communication Skills, Data Analysis, Detail Oriented, Documentation, Electronic Measuring Tools, Experiment Design, Hardware Quality Assurance, Industry Standards, LabVIEW Programming Language, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Production Testing, Mechanical Engineering, Medical Equipment, Operations Processes, Oscilloscope, Problem Solving Skills, Process Validation, Product Development, Product Engineering, Product Testing, Production Systems, Python Programming/Scripting Language, Quality Assurance Methodology, Quality Engineering, Quality Management, Requirements Management, Software Design, Team Player, Technical Support, Test Automation, Test Equipment, Test Fixtures, Test Plan/Schedule, Test Requirements, Test Scripts, Testing, Validation Testing
LOCATION
Irvine, CA
POSTED
30+ days ago
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.

About the Company

K

Katalyst Healthcares & Life Sciences

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