Device Development Engineer Role Overview
The Device Development Engineer will play a key role in ensuring the design and development of combination products meet regulatory requirements.
This involves working with cross-functional teams to develop and maintain Design History Files, and collaborating with affiliates and third parties to ensure compliance with program deliverables.
Additionally, the engineer will support the integration of acquired combination products into the global product portfolio and assess compliance with design control requirements.
Key responsibilities include implementing ISO 14971:2019 for risk management activities, supporting device development and manufacturing operations, and demonstrating knowledge of GMP, Quality Management System, and relevant regulations.
What You'll Need to Succeed
* Education – Degree / Masters in engineering or science/life science
* Industry – Medical Device or Pharmaceutical (with devices)
* Min 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 as applicable to device design
* Demonstrated understanding of GMP, Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971)
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