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.
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.
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 xphnsxz 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