Medical Device Engineer Lead

A global pharmaceutical organisation is seeking a Medical Device Engineer Lead to drive a high-impact lifecycle management programme for a flagship on-market combination product .

This role leads the implementation of a second-source primary packaging solution , a strategically critical risk-mitigation initiative comparable in complexity to a new product development.

You will act as the technical project owner , leading design verification, design validation, and process validation activities, while ensuring full compliance with medical device regulations, GMP, and the Quality Management System.

Key Responsibilities

• Lead the second-source primary packaging programme for an on-market combination product.
• Own technical strategy, scope, timelines, and execution.
• Drive design verification, design validation, and process validation activities.
• Create and maintain technical documentation (DHF updates, risk files, FMEA, ISO 14971).
• Coordinate cross-functional stakeholders (quality, regulatory, packaging, supply, industrial).
• Manage external suppliers and partners across Belgium and Switzerland.
• Support regulatory submissions related to lifecycle changes.
• Identify and mitigate technical and regulatory risks.
• Provide technical guidance to junior engineers within the team.

Required Background

• Master’s degree in Engineering, Life Sciences, Pharmacy, or similar.
• 5–8 years’ experience in medical devices and/or combination products.
• Strong experience with lifecycle management of on-market devices.
• Solid knowledge of ISO 13485, EU MDR, FDA 21 CFR 820, ISO 14971, GMP.
• Excellent technical documentation and stakeholder communication skills.
• Fluent English.

Nice to have

• Experience with drug delivery devices (e.g. autoinjectors).
• Exposure to second-sourcing or supplier change programmes.
• French language skills.