Medical Device Engineer – Drug Delivery & Lifecycle

BioTalent; Brussel; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

BioTalent supports a leading global biopharmaceutical company in hiring a Medical Device Engineer for the Devices, Artwork & Packaging team. You will design, develop, industrialize, and lifecycle manage innovative drug delivery systems and combination products.

In this role, you will work in a collaborative international environment to ensure quality, regulatory, safety, and performance requirements from development through post-market activities, including DHF management and device validations.

Qualifications

• Bachelor's or Master’s degree in Engineering or a related discipline.
• Minimum 3 years of experience in medical devices, pharma, biotech or combination products.
• Experience with Design Controls, Design Verification & Validation, and Design History File (DHF) management.
• Familiarity with ISO 14971 and GMP environments.

Responsabilités

• Support the design, development, and industrialization of medical devices and drug-device combination products.
• Coordinate technical activities across development, validation, commercialization, and lifecycle management projects.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners.
• Manage and maintain Design History Files (DHF) and related design control documentation.
• Contribute to design verification, design validation, process validation, and regulatory submission activities.
• Support risk management activities in accordance with ISO 14971 requirements.
• Drive lifecycle management initiatives, change controls, and continuous improvement for marketed devices.
• Evaluate new device technologies and contribute to feasibility and innovation assessments.
• Ensure compliance with applicable medical device regulations, GMP requirements, and quality management systems.

Connaissances

Project management

Stakeholder management

Communication

Cross-functional collaboration

Formation

Bachelor's or Master’s degree in Engineering or related discipline

Description du poste

BioTalent supports a leading global biopharmaceutical company in hiring a Medical Device Engineer for the Devices, Artwork & Packaging team. You will design, develop, industrialize, and lifecycle manage innovative drug delivery systems and combination products.

In this role, you will work in a collaborative international environment to ensure quality, regulatory, safety, and performance requirements from development through post-market activities, including DHF management and device validations.