Medical Device Engineer

Overview

An opportunity for a Medical Device Engineer to support the lifecycle management of drug delivery systems and combination products within a regulated GMP environment.

This role focuses on technical operations , including complaint handling, change control, and maintenance of design and risk documentation, ensuring ongoing compliance with medical device regulations.

The role is an initial 2 year contract, working three days onsite near brussels.

Key Responsibilities

• Lead complaint investigations , performing root-cause analysis and driving CAPA activities
• Manage deviations and change controls across materials, components, processes, and suppliers
• Maintain Design History Files (DHF) and risk management documentation (e.g. FMEA) in line with ISO 14971
• Support shop-floor investigations and collaborate closely with manufacturing teams
• Contribute to lifecycle management activities for marketed devices, including design and supplier changes
• Coordinate with cross-functional teams (Quality, Regulatory, Supply Chain) and external partners
• Support post-market surveillance and regulatory commitments where required
• Ensure compliance with QMS and GMP requirements and contribute to continuous improvement initiatives