Job Summary :

Provide design assurance support for new product development and on-market medical devices, ensuring compliance with design controls, regulatory standards, and manufacturability improvements. Collaborate with cross-functional teams to facilitate design validation, risk management, and regulatory compliance.

Key Responsibilities :

• Lead design verification and validation activities for new and sustaining product development.
• Coordinate risk management files and Health Risk Assessments for product compliance.
• Manage change requests, assess design impacts, and ensure proper documentation.
• Ensure product compliance with FDA QSR, ISO 13485, and other relevant standards.

Education :

• Bachelor’s degree in a technical field

Skills :

• Experience with FDA QSR, ISO 13485, ISO 14970, and risk management
• Knowledge of product testing, verification, and validation processes
• Strong communication and teamwork skills, with leadership abilities on critical tasks

Preferred :

• Experience with test method validation, root cause analysis, and statistical methods