What are the responsibilities and job description for the New Product Development Engineer position at Katalyst CRO?
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.
- 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.
- 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).
- 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.