Galway - Design Assurance Engineer New

Design Assurance Engineer

Summary:

Support the ongoing maintenance of commercial products throughout their full lifecycle, ensuring compliance with global quality and regulatory standards. Collaborate cross-functionally to implement product, process, or material changes while assessing and mitigating patient risk.

Key Responsibilities:

• Ensure sustained compliance of commercial products through all phases of the product lifecycle.
• Evaluate and manage design changes in alignment with regulatory and quality requirements.
• Provide QA technical direction for product qualification and validation in collaboration with R&D and Manufacturing Engineering.
• Generate design verification protocols and participate in compiling verification and shelf-life data for regulatory submissions.
• Interface with Regulatory Affairs to present data clearly and minimize questions from regulatory agencies.
• Build strong working relationships across R&D, Regulatory Affairs, Quality, and Manufacturing teams.
• Support implementation of design, process, and material changes within manufacturing operations.
• Maintain current knowledge of global regulatory and compliance requirements (e.g., FDA, ISO 13485:2016, ISO 14971:2019).
• Generate and approve change requests and ensure documentation meets regulatory standards.
• Lead or support timely investigations and root cause analysis for quality issues.

• Apply risk management principles throughout product development and post-market activities.
• Ensure risks are properly assessed, documented, and mitigated per industry standards.
• Collaborate with engineering and manufacturing to ensure quality standards are met.
• Design or specify inspection/test mechanisms and conduct quality assurance testing.
• Perform statistical analysis on nonconforming materials to determine root cause and assign responsibility.
• Ensure corrective actions meet reliability and documentation standards.
• Provide support in design, incoming material quality, production control, product evaluation, inventory control, and/or R&D quality as applicable.
• Partner with the complaints team for complex product investigations and resolution.

Preferred Qualifications:

• Strong knowledge of FDA regulations and ISO standards (13485, 14971).
• Experience in sustaining engineering, design assurance, or medical device quality systems.
• Demonstrated ability to manage risk, drive quality improvements, and support regulatory submissions.

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