Medical Device Engineer (Combination Products)

We are supporting a global pharmaceutical organisation in hiring a Medical Device Engineer to support the design, development, industrialisation and lifecycle management of drug delivery systems. The role sits within a multidisciplinary device organisation and works closely with internal programme teams and external partners across global projects.

Key Responsibilities:

• Support design, development and industrialisation of drug delivery devices from NPI through lifecycle management
• Ensure compliance with medical device regulations and GMP for combination products
• Contribute to device verification, validation, process validation and regulatory submissions
• Support creation and maintenance of Design History Files (DHF)
• Coordinate technical activities with internal stakeholders and external suppliers
• Support post‑market activities, change management and secondary regulatory submissions
• Contribute to evaluation of new device technologies and platforms

Requirements:

• Degree in Engineering or related scientific discipline
• 3+ years’ experience within pharma, biotech or medical devices
• Strong knowledge of ISO 13485, ISO 14971, MDR, 21 CFR 820, 21 CFR 4
• Experience with combination products and GMP environments
• Strong communication skills in cross‑functional and matrix teams

Nice to Have:

• Project management or Green Belt certification
• Experience working with external device manufacturers or CDMOs