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.
Risk Management
- 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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