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Device development expert

Dublin
beBeeEngineering
Posted: 28 August
Offer description

Job Description:

We are seeking a skilled Principal Device Development Engineer to join our team. In this role, you will be responsible for supporting and providing guidance for device development programs throughout the design and development lifecycle. This includes ensuring compliance with design control requirements outlined in Quality Management System, and relevant Regulations.

You will establish, maintain, and provide guidance on the contents of Design History Files for development programs. This will include associated activity plans and timelines. Additionally, you will collaborate with affiliated sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.

In this role, you will support the integration, and assess compliance with design control requirements, of acquired combination products and medical devices, into the Global Device Development product portfolio. You will also support Risk Management activities for development programs through the implementation of ISO 14971:2019.

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Required Skills and Qualifications:

* Educational background - Degree / 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 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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What You Will Achieve:

This role offers the opportunity to work on complex device development projects and contribute to the success of our company. You will have the chance to develop your skills and expertise in device development and manufacturing operations.

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