Design Assurance Engineer

EPM Scientific; Galway; Sur place; EUR 60 000 - 95 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Design Assurance

Risk Management

Regulatory Compliance

CAPA

Change Control

ISO 14971

DFMEA

PFMEA

Validation

Cross-functional

Description du poste

Our client is seeking an experienced Design Assurance Engineer to support a strategic product transfer programme within a regulated medical device environment. This individual will serve as the quality representative between R&D and Manufacturing, ensuring product design intent, risk controls, and regulatory requirements are maintained throughout the transfer process.

The successful candidate will work closely with R&D, Quality, Manufacturing Engineering, Regulatory Affairs, and Operations teams to ensure the seamless transfer of products from development into commercial manufacturing.

Overview

Our client is seeking an experienced Design Assurance Engineer to support a strategic product transfer programme within a regulated medical device environment. This individual will serve as the quality representative between R&D and Manufacturing, ensuring product design intent, risk controls, and regulatory requirements are maintained throughout the transfer process.

The successful candidate will work closely with R&D, Quality, Manufacturing Engineering, Regulatory Affairs, and Operations teams to ensure the seamless transfer of products from development into commercial manufacturing.

Key Responsibilities

• Lead Design Assurance activities supporting product transfer and product lifecycle projects.
• Act as a key liaison between R&D and Manufacturing to ensure successful transfer of products and processes.
• Partner with R&D teams to understand design intent, critical product requirements, and risk controls.
• Drive Risk Management activities in accordance with ISO 14971.
• Develop, review, and maintain Risk Management Files, Hazard Analyses, dFMEAs and pFMEAs.
• Assess the impact of design, process, material, supplier, and manufacturing changes on product performance and patient safety.
• Support design reviews and provide quality and risk-based guidance to project teams.
• Ensure Design Control requirements are maintained throughout development and transfer activities.
• Collaborate with R&D, Operations, Manufacturing Engineering, Quality, Supply Chain, and Regulatory Affairs functions to resolve technical challenges.
• Support design verification, validation, and transfer-related activities as required.
• Review and approve validation documentation, technical reports, and change controls.
• Participate in CAPA investigations, root cause analysis, and continuous improvement activities.
• Communicate project risks, issues, and mitigation plans effectively across cross-functional teams.