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.