Senior Design Quality Engineer – Medical Devices, Galway

Medtronic; Galway; Hybrid; EUR 65,000 - 97,000; Full time

Job summary

Medtronic in Galway, Ireland, is seeking a Sr. Design Quality Engineer to support Released Product Engineering for the ACM unit.

You will drive design controls, risk management, and change control across medical device products, ensuring compliance with ISO 13485, EU-MDR, and FDA QSR. You will lead cross-functional teams to build risk management files, verify and validate tests, and review designs for patient safety and reliability.

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.
• Good verbal and written communication skills in English, including protocol/report development.

Responsibilities

• Critically review new and modified product designs for patient safety, standards compliance, and reliability.
• Ensure design changes comply with Medtronic's QMS, ISO13485, EU-MDR and FDA QSR.
• Lead cross-functional teams to develop product risk management files (risk management 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

English communication

Education

Bachelor's Degree

Master's Degree

Job description

Medtronic in Galway, Ireland, is seeking a Sr. Design Quality Engineer to support Released Product Engineering for the ACM unit.

You will drive design controls, risk management, and change control across medical device products, ensuring compliance with ISO 13485, EU-MDR, and FDA QSR. You will lead cross-functional teams to build risk management files, verify and validate tests, and review designs for patient safety and reliability.