Senior Design Assurance Engineer – MedTech Quality

Actalent; Galway; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Actalent seeks a Senior Design Assurance Engineer for a medical device client in Ireland. The role focuses on ensuring products meet regulatory and quality standards across R&D, quality, regulatory, and manufacturing.

You will shape verification/validation, risk management and product transfer to manufacturing. You will collaborate across functions to drive CAPA, investigations and continuous improvement, influencing product quality throughout the lifecycle and supporting successful

Qualifications

• Degree in Engineering, Science or related STEM field.
• Experience in Medical Device industry.
• Knowledge of FDA & ISO regulatory requirements.
• Experience with DFMEA/PFMEA and risk management.

Responsabilités

• Lead and support Design Verification and Design Validation activities.
• Drive Design Controls, Design Review and Design Change processes.
• Support regulatory submissions and compilation of technical documentation.
• Lead CAPA, root cause investigations and continuous improvement initiatives.
• Develop and improve test methods, protocols and engineering documentation.
• Support Human Factors and Usability studies.
• Perform and review risk management activities including DFMEA/PFMEA.
• Support product transfer from design into manufacturing.
• Collaborate with external design, manufacturing and supplier partners.
• Provide technical leadership to cross-functional teams.

Connaissances

Design Controls

Risk Management

Root Cause Analysis

Regulatory Submissions

Formation

Engineering/Science degree

Description du poste

Actalent seeks a Senior Design Assurance Engineer for a medical device client in Ireland. The role focuses on ensuring products meet regulatory and quality standards across R&D, quality, regulatory, and manufacturing.

You will shape verification/validation, risk management and product transfer to manufacturing. You will collaborate across functions to drive CAPA, investigations and continuous improvement, influencing product quality throughout the lifecycle and supporting successful