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 :, ISO :).Generate and approve change requests and ensure documentation meets regulatory standards.Lead or support timely investigations and root cause analysis for quality issues.Risk ManagementApply 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 (, ).Experience in sustaining engineering, design assurance, or medical device quality systems.Demonstrated ability to manage risk, drive quality improvements, and support regulatory submissions.#LI-MS2