Job ResponsibilityResponsibility:
1. Design engineering study features, such as sampling, testing, or analytical methodologies.
2. Draw samples of raw materials, or intermediate and finished products for engineering testing.
3. Conduct engineering, validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
4. Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
5. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for medical, electronics, or other types of production.
6. Analyze engineering test data to determine whether systems or processes have met acceptance criteria or to identify root causes of production problems.
7. Perform IQ/CQ/OQ/PQ activities for equipment/machine/jig and process.
8. Create, populate or maintain databases for tracking engineering activities, test results or validated systems.
9. Identify deviations from established product or process standards and provide recommendations for resolving deviations.
10. Prepare detailed reports or design statements based on results of engineering tests or reviews of procedures and protocols.
11. Resolve testing problems by modifying testing methods or revising test objectives and standards.
12. Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
13. Assist in training equipment operators or other staff on engineering protocols and standard operating procedures.
14. Participate in internal or external training programs to maintain knowledge of engineering principles, industry trends, or novel technologies.
15. Perform task as assigned by superior.
16. Continuous support for ISO 13485.
Job RequirementsJob Benifits
