Senior Design Quality Engineer, Medical Devices & Risk

IE5 COV - Nellcor Puritan Bennett IRL; Galway; On-site; EUR 65,000 - 97,000; Full time

Job summary

Medtronic is seeking a Sr. Design Quality Engineer in Ireland to support Released Product Engineering for the Acute Care & Monitoring unit.

You will lead cross-functional teams, assess risk management files, and ensure compliance with ISO13485, EU-MDR, and FDA standards while advancing product quality across ACM portfolio. The role requires strong problem-solving, attention to detail, and expertise in design controls, verification/validation, and CAPA processes to improve patient safety and

Qualifications

• 4+ years of Quality experience with a Bachelor's Degree.
• 2+ years of Quality experience with a Master's Degree.
• Experience in the Medical Device Industry or a similar role.
• Excellent verbal and written English communication; protocol/report development.

Responsibilities

• Critically review new and modified product designs to determine impact on requirements, patient safety, standards compliance, and reliability.
• Ensure design changes comply with Medtronic's QMS, ISO13485, EU-MDR and FDA QSRs.
• Lead cross-functional teams to develop product risk management files (risk management plan, risk assessments, dfMEA, risk management report).
• Assist in creation of verification and validation test plans, protocols and reports.
• Review testing and analysis for standards and product requirements compliance.

Skills

ISO 13485

Risk Management

CAPA & RCA

EU-MDR

IEC Standards

Education

Bachelor's Degree

Master's Degree

Tools

Minitab

Stat Graphics

Statistical Software

Job description

Medtronic is seeking a Sr. Design Quality Engineer in Ireland to support Released Product Engineering for the Acute Care & Monitoring unit.

You will lead cross-functional teams, assess risk management files, and ensure compliance with ISO13485, EU-MDR, and FDA standards while advancing product quality across ACM portfolio. The role requires strong problem-solving, attention to detail, and expertise in design controls, verification/validation, and CAPA processes to improve patient safety and