Validation Engineer - Coforge - San Francisco, CA (Onsite)

[Naveen Beast]

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Job Title: Validation Engineer

Location: San Francisco, CA (Onsite)

Implementation: Coforge

Algorithm Validation specialist for CSV validation of ML algorithms for various imaging systems built by data scientists.

 

Job Responsibilities:

• Strong understanding of clinical imaging workflows and machine learning (ML) validation within the framework of Good Clinical Practices (GCP).
• Design and execute validation protocols for ML algorithms applied to imaging data (built by Data Scientists in the organization).
• Ensure compliance with GCP, FDA, and other relevant regulatory guidelines during algorithm testing and deployment.
• Maintain documentation for validation activities in accordance with GCP.
• Support audits and regulatory submissions by providing detailed validation reports to quality management teams.
• Work closely with data scientists, software engineers, and CRO’s to integrate validated ML models into clinical workflows.
• Strong communication and leadership skills to drive validation of algorithms with different stakeholders

 

Preferred Qualifications

• Strong understanding of ML algorithms used in Radiology and Digital pathology area.
• Prior experience in validating ML algorithms with Pharma companies.
• Prior experience of SaMD (Software as medical device) compliance of imaging software, ML algorithms used in reading radiology/pathological images.