Design Quality Engineer

About the role

We are seeking a Design Quality Engineer to ensure quality assurance, compliance, and product integrity throughout the development, verification, validation, and sustaining phases of medical device engineering. You will work closely with cross‑functional teams to guarantee that designs meet rigorous regulatory standards.

Key responsibilities

• Partner with design, development, and manufacturing teams to verify design requirements and validate product performance.
• Ensure full compliance with ISO 13485, EU MDR, and FDA QMSR standards.
• Lead risk assessment activities, review verification & validation (V&V) protocols and reports, and manage Engineering Change Notices (ECNs).
• Apply statistical methods to design data and create, test, and implement test method validations for new and existing products.
• Drive complaint investigations, identify design quality system gaps, and promote a strong quality culture.

Required profile

• Bachelor’s degree in Engineering or a related scientific field (industrial, chemical, materials, mechanical, electrical, electronic, etc.).
• Minimum 3 years of design or manufacturing experience in the medical‑device industry.
• Strong working knowledge of ISO 13485, EU MDR, and FDA QMSR standards.
• English proficiency at B2 level or higher.
• Excellent attention to detail, strong organization and time‑management skills, and ability to handle multiple projects simultaneously.

Required skills

• Risk assessment methodology
• Statistical analysis of design data
• Verification & validation (V&V) protocol development and review
• Engineering Change Notice (ECN) management
• Test method validation (TMV) creation and execution
• ISO 13485 compliance
• EU MDR compliance
• FDA QMSR compliance