Innovative Product Development Specialist

We are seeking a dedicated and detail-oriented Quality Development Engineer to play a crucial part in sustaining NPI projects from a Design Control standpoint.

• Support the maintenance of user requirements, product requirements, product specifications and the traceability between product requirements, design and test items.
• Collaborate cross-functionally to support completion and maintenance of product risk management deliverables to establish and maintain safe and effective products and processes.
• Develop verification test plans and reports.
• Review design control deliverables in compliance with IEC 80601-2-77, IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2.
• Develop Device History Files (DHF) to ensure content is complete, accurate and compliant with regulatory standards.
• Support quality system-related deliverables including nonconformances and Corrective Action Preventive Action (CAPA).

Job Requirements :

• Degree level qualification from a science / engineering background.
• Experience working with class IIa / IIb Medical Devices.
• Deep knowledge of ISO 13485.
• Experience with ISO 14971 Risk Management.
• Deep knowledge of IEC 60601
• standards.
• Business fluent English skills.
• Good technical writing skills.

We offer an exciting and challenging role based in Pisa, Italy. Work in a fun and growing company dedicated to improving patient care. The chance to learn new skills under the direction of experienced colleagues with career advancement opportunities. Join us and grow with a team of energetic people who will motivate and inspire you.

We are committed to creating a diverse work environment and are proud to be an equal opportunity employer. We welcome applications from all qualified candidates without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, pregnancy, age, disability or other characteristics protected by law.