Device Development Engineer Role Overview
We are seeking a highly skilled Device Development Engineer to support device development programs throughout the design and development lifecycle.
* Ensure compliance with design control requirements, establish and maintain Design History Files, and collaborate with affiliated sites and third parties.
Key Responsibilities:
The successful candidate will be responsible for:
* Supporting device development programs, ensuring compliance with design control requirements and international standards.
* Maintaining and providing guidance on Design History Files for various program types.
* Collaborating with affiliated sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained.
* Supporting the integration of acquired combination products and medical devices into the product portfolio.
Requirements:
To be successful in this role, you will need:
* Education: A degree or masters in engineering or science/life science.
* Industry experience: Medical Device or Pharmaceutical (with devices).
* Minimum 5-7 years at similar level or 5-10 years general experience in industry.
* Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.
* Experience in the implementation of device design controls and ISO/FDA requirements.
* Demonstrated understanding of GMP, Quality Management System, and relevant Regulations and International Device Standards.