Technical Architect

Job Summary

JOB description:

• Communicate effectively with program leadership to ensure clear expectations, demonstrate progress, and identify issues. Provide progress updates and regular reporting to business and functions leadership.
• Systems Lead responsible for driving combination product development. Complete requirements analysis, component selection, design, development, testing, systems integration, documentation, and new product development to support the life cycle and new product development.
• Plan and perform lab work to support the development of drug delivery systems.
• Execute formulation and associated analytical experiments.
• Good understanding of Pre-clinical and Clinical phases of Pharma development
• Test Method Validation of Physical Test Methods for Medical Devices/Combination Products
• Maintain timely and accurate laboratory records consistent with good documentation practices.
• Strong experience in Risk Management with specific focus in Use Related Risk Assessment
• Good Knowhow on ICH, EU MDR Standards
• Generate high-quality data and prepare technical reports/presentations.
• Support a safe, organized, and operational laboratory environment, including coordination of equipment calibration/maintenance, procurement of supplies, etc.
• Work experience with NPD/Sustenance projects involving combination product, medical device & laboratory instruments.
• Knowledge on medical standards ISO 13485 & ISO 14971.
• Should have thorough knowledge on Engineering change control process (ECO/ECN)
• Successfully influences stockholders and cross functional team member within the project

Key Responsibilities

This is an alternate SR created on behalf of 82794 Due to band Mismatch

Skill Requirements

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Other Requirements

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