Medical Device Engineer

BioTalent; Brussel; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Project management

Stakeholder management

Communication

Cross-functional collaboration

Formazione

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

Descrizione del lavoro

We are supporting a leading global biopharmaceutical company in the search for a Medical Device Engineer to join their Devices, Artwork & Packaging team. In this role, you will support the design, development, industrialization, and lifecycle management of innovative drug delivery systems and combination products. Working within a highly collaborative international environment, you will ensure medical devices meet quality, regulatory, safety, and performance requirements from early development through commercialization and post-market activities.

Responsibilities

• 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 cross-functional teams including Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners.
• Manage and maintain Design History Files (DHF) and associated 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 projects 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.

Must-Have Requirements

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related discipline.
• Minimum 3 years of experience within the medical device, pharmaceutical, biotech, or combination product industry.
• Experience supporting the development and lifecycle management of medical devices or drug delivery systems.
• Strong understanding of medical device regulations and standards, including ISO 13485 and MDR.
• Knowledge of Design Controls, Design Verification & Validation, and Design History File (DHF) management.
• Familiarity with risk management principles and ISO 14971.
• Experience working within GMP-regulated environments.
• Strong project management and stakeholder management skills in cross-functional environments.
• Excellent communication skills with the ability to influence internal and external stakeholders.

Preferred Qualifications

• Experience with autoinjectors, pen injectors, wearable injectors, prefilled syringes, or other drug delivery devices.
• Knowledge of 21 CFR 820, 21 CFR Part 4, and combination product regulations.
• Green Belt, Lean Six Sigma, or Project Management certification.
• Experience working with external device manufacturers and development partners.