Senior Design Assurance Engineer

The purpose of this role is to provide Design Control and Quality Engineering support for medical device products within a manufacturing environment. The position supports product development, regulatory compliance, and manufacturing quality, contributing to the successful commercialization of products and overall business growth.

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• Act as the Quality representative and core team member on New Product Commercialization (NPC) projects.
  
• Lead and support Design Control activities, ensuring compliance with applicable regulatory and quality standards.
  
• Facilitate risk management activities, including Risk Assessments and Design Failure Mode and Effects Analysis (DFMEA).
  
• Support the development and review of product specifications, engineering drawings, and technical documentation.
  

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• Contribute to Process Failure Mode and Effects Analysis (PFMEA) and process validation activities for new product introduction projects.
  
• Provide quality guidance and oversight during product and process development.
  

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• Perform internal audits in accordance with the annual audit schedule to ensure compliance with ISO 13485 and FDA Quality System Regulations (QSR).
  
• Ensure design and development activities meet all applicable regulatory and quality requirements.
  

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• Support Corrective and Preventive Action (CAPA) investigations and implement effective solutions related to new product projects and manufacturing processes.
  
• Perform statistical analysis to support validation activities and continuous improvement initiatives.
  

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• Provide training and guidance to personnel on quality procedures, design controls, and regulatory requirements as required.
  

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• 5–8 years of experience in the medical device industry.
  
• Demonstrated experience with:
  
• Design Controls
  
• New Product Introduction (NPI/NPC)
  
• Statistical analysis
  
• Process validation
  

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• Bachelor’s degree in Engineering or a related Science discipline.
  
• Professional quality qualification preferred, such as Certified Quality Engineer (CQE). xcfaprz
  
• Experience working in regulated environments aligned with ISO 13485 and FDA requirements.