Job Summary:

Ensure design assurance for new and existing medical devices, maintaining regulatory compliance, facilitating design controls, and supporting manufacturability and cost-reduction efforts.

Key Responsibilities:

• Lead design verification and validation activities for new product development.
• Review and audit Design History Files (DHF) for medical devices, ensuring compliance with design controls.
• Maintain and verify accuracy of Requirements Trace Matrix for compliance.
• Support sustaining product projects, ensuring completion of verification, validation, and risk management activities.
• Collaborate with R&D to ensure Risk Management files meet standards.
• Coordinate Health Risk Assessments for on-market products.
• Evaluate design change requests and assess their impact.

Qualifications:

• Education: Bachelor’s degree in a technical field.
• Experience: 2-5 years in the medical device industry.

Skills:

• Familiar with FDA QSR, ISO 13485, ISO 14971, and Medical Device Directive.
• Knowledge of verification, validation, risk management, and design controls.
• Strong documentation and compliance assessment skills.