Medical Device- NPI Manufacturing Engineer - Katalyst Healthcares & Life Sciences

• Design and implement automated unit and integration test for robotic hardware and/or PCAs.
• Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports.
• Help to structure new software and refactor existing software for testability.
• Develop test scripts to automate test data collection and analysis.
• Design, develop, maintain, and improve manufacturing processes, equipment, and tooling.

Requirements:

• 4+ years of experience.
• Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is highly preferred.
• Experience with Process Validation (IQ/OQ/PQ), able to generate protocols and test reports.
• Able to demonstrate an understanding of Failure Modes and Effects Analysis and Fault Tree Analysis, preferably in an electro-mechanical.
• Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.