Design Assurance Engineer – Medical Device Transfer Lead

EPM Scientific; Galway; On-site; EUR 60,000 - 95,000; Full time

Job summary

EPM Scientific in Ireland seeks an experienced Design Assurance Engineer to support a strategic product transfer programme within a regulated medical device environment. You will act as the quality representative between R&D and Manufacturing, ensuring design intent, risk controls, and regulatory compliance are maintained throughout the transfer.

The successful candidate will collaborate with R&D, Quality, Regulatory Affairs, Operations, and Manufacturing Engineering to ensure the seamless

Qualifications

• Experience in medical device design assurance and transfer projects.
• Strong knowledge of risk management per ISO 14971.
• Familiarity with design controls and validation/verification processes.

Responsibilities

• Lead design assurance activities for product transfer and lifecycle projects.
• Act as liaison between R&D and Manufacturing to ensure smooth transfer of products.
• Collaborate with R&D to understand design intent and risk controls.
• Drive risk management activities and maintain Risk Management Files (dFMEAs/pFMEAs).
• Assess impact of design/process changes on product performance and patient safety.
• Support design reviews and provide quality guidance to project teams.
• Ensure Design Control requirements are maintained during development and transfer.

Skills

Design Assurance

Risk Management

Regulatory Compliance

CAPA

Change Control

ISO 14971

DFMEA

PFMEA

Validation

Cross-functional

Job description

EPM Scientific in Ireland seeks an experienced Design Assurance Engineer to support a strategic product transfer programme within a regulated medical device environment. You will act as the quality representative between R&D and Manufacturing, ensuring design intent, risk controls, and regulatory compliance are maintained throughout the transfer.

The successful candidate will collaborate with R&D, Quality, Regulatory Affairs, Operations, and Manufacturing Engineering to ensure the seamless