Design Assurance Engineer
Overview
Our client is seeking an experienced Design Assurance Engineer to support a strategic product transfer programme within a regulated medical device environment. This individual will serve as the quality representative between R&D and Manufacturing, ensuring product design intent, risk controls, and regulatory requirements are maintained throughout the transfer process.
The successful candidate will work closely with R&D, Quality, Manufacturing Engineering, Regulatory Affairs, and Operations teams to ensure the seamless transfer of products from development into commercial manufacturing.
Key Responsibilities
- Lead Design Assurance activities supporting product transfer and product lifecycle projects.
- Act as a key liaison between R&D and Manufacturing to ensure successful transfer of products and processes.
- Partner with R&D teams to understand design intent, critical product requirements, and risk controls.
- Drive Risk Management activities in accordance with ISO 14971.
- Develop, review, and maintain Risk Management Files, Hazard Analyses, dFMEAs and pFMEAs.
- Assess the impact of design, process, material, supplier, and manufacturing changes on product performance and patient safety.
- Support design reviews and provide quality and risk-based guidance to project teams.
- Ensure Design Control requirements are maintained throughout development and transfer activities.
- Collaborate with R&D, Operations, Manufacturing Engineering, Quality, Supply Chain, and Regulatory Affairs functions to resolve technical challenges.
- Support design verification, validation, and transfer-related activities as required.
- Review and approve validation documentation, technical reports, and change controls.
- Participate in CAPA investigations, root cause analysis, and continuous improvement activities.
- Communicate project risks, issues, and mitigation plans effectively across cross-functional teams.
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