Validation Engineer II Job Description

We are seeking a skilled Validation Engineer II to join our team and contribute their expertise in regulated medical device manufacturing environments.

The ideal candidate will have experience in providing technical engineering support for validation activities including compliance with FDA and ISO 13485 requirements. They should be knowledgeable about medical devices, quality systems, and regulatory standards. The following skills and qualifications are required:

1. >Technical expertise in design verification testing of software or hardware components of the medical device system.


2. >Understanding of risk management methodologies (e.g., FMEA) as applied to the design process of Class III high-risk


3. >Knowledgeable about test equipment calibration
   Proven ability to manage project tasks under deadlines while maintaining accurate documentation.
   
   
 
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