Senior Design Assurance Engineer — MedTech Impact

Actalent; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Actalent is recruiting a Senior Design Assurance Engineer to join a medical device organisation focused on cancer patient care. This role sits within the Quality and Product Development team, supporting the expansion of a growing product portfolio as the business transitions from development into commercialisation.

The successful candidate will drive product quality throughout the lifecycle, from concept through verification, validation and manufacturing transfer, working at the intersection of

Qualifications

• Degree in Engineering, Science or a related STEM discipline.
• Experience in Medical Device industry.
• Strong knowledge of Design Controls and Design Change processes.
• Experience with ISO 13485 Quality Management System and DFMEA/PFMEA.

Responsibilities

• 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 and support 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 and PFMEA.
• Support product transfer from design into manufacturing.
• Work closely with external design, manufacturing and supplier partners.
• Provide technical leadership, coaching and guidance to cross-functional teams.

Skills

Design Controls

Risk Management

Regulatory Submissions

Root Cause Investigation

Cross-functional Leadership

Communication Skills

Problem-Solving

Education

Engineering degree or related STEM

Job description

Actalent is recruiting a Senior Design Assurance Engineer to join a medical device organisation focused on cancer patient care. This role sits within the Quality and Product Development team, supporting the expansion of a growing product portfolio as the business transitions from development into commercialisation.

The successful candidate will drive product quality throughout the lifecycle, from concept through verification, validation and manufacturing transfer, working at the intersection of