Design Quality Engineer - Risk & MDR (Limerick On-site)

RED Global; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

RED Global is partnering with a global Life Sciences company to hire Design Quality Engineers on a permanent basis. The role requires four days per week onsite in County Limerick, with the on-site pattern being non-negotiable.

The ideal candidate will bring hands-on Design Quality experience in regulated product development, with strong risk management and the ability to challenge designs across multiple SMEs. A solid understanding of ISO 13485 and EU MDR is essential.

Qualifications

• Hands-on Design Quality experience in regulated development.
• Strong knowledge of ISO 13485 and EU MDR requirements.
• Experience with design controls, V&V, risk assessments, and change control.
• Able to collaborate with SMEs and ensure traceability of design history files.

Responsibilities

• Support design controls throughout product development lifecycle.
• Review design inputs/outputs, requirements and specifications.
• Lead/design risk management activities including DFMEA/FMEA and hazard analysis.
• Ensure risks and controls are linked to design requirements and V&V.
• Maintain Design History Files and cross-functional communication with SMEs.

Skills

Design Quality

Risk Management

ISO 13485

EU MDR

Design Controls

V&V

Medical Device Industry

Job description

RED Global is partnering with a global Life Sciences company to hire Design Quality Engineers on a permanent basis. The role requires four days per week onsite in County Limerick, with the on-site pattern being non-negotiable.

The ideal candidate will bring hands-on Design Quality experience in regulated product development, with strong risk management and the ability to challenge designs across multiple SMEs. A solid understanding of ISO 13485 and EU MDR is essential.