Senior Design Quality Engineer – Medical Devices

Medtronic; Galway; On-site; EUR 65,000 - 97,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Medtronic, a global leader in healthcare technology, is seeking a Senior Design Quality Engineer to support Released Product Engineering for the Acute Care & Monitoring unit. You will ensure design changes meet QMS, risk management, and regulatory requirements while collaborating across functions to deliver safe, compliant medical devices.

Join a team focused on technical excellence and continuous improvement, applying design controls, risk assessments, and CAPA in the evaluation and release of

Qualifications

• Experience in the Medical Device Industry or a similar role.
• Good verbal and written communication skills in English.
• Experience in ISO 13485.
• Experience in Risk Management ISO 14971.
• Working knowledge of IEC standards.
• Familiar with IEC 60601 and product standards.
• Experience of EU-MDR regulations.
• Experience of CAPA and root cause failure analysis.

Responsibilities

• Critically review new and modified product designs to determine impact on requirements, patient safety, standards compliance and reliability.
• Ensure design changes to existing products are compliant with QMS, ISO13485, EU-MDR and FDA Quality System Regulations.
• Lead cross-functional teams to develop product risk management files (risk plan, risk assessments, dFMEA, risk management report).
• Assist in the creation of verification and validation test plans, protocols and reports; review testing and analysis for standards and product requirements compliance.

Skills

Quality experience

Cross-functional teams

Problem solving

English communication

Education

Bachelor's Degree

Master's Degree

Tools

ISO 13485

ISO 14971

IEC standards

EU-MDR

CAPA

Verification & Validation

Job description

Medtronic, a global leader in healthcare technology, is seeking a Senior Design Quality Engineer to support Released Product Engineering for the Acute Care & Monitoring unit. You will ensure design changes meet QMS, risk management, and regulatory requirements while collaborating across functions to deliver safe, compliant medical devices.

Join a team focused on technical excellence and continuous improvement, applying design controls, risk assessments, and CAPA in the evaluation and release of