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Magenta Medical is seeking a Design Quality Assurance Engineer to join its growing Design QA team. This role offers a unique opportunity to contribute at a high-impact phase of product development as the company advances toward Pre-Market Approval (PMA).
You will collaborate closely with R&D, Engineering, and Manufacturing teams to support the design and development process while ensuring regulatory compliance. Key responsibilities include:
• Ensure design and development activities comply with applicable procedures and approved design and development plans
• Provide quality and compliance input throughout the design and development lifecycle
• Review and approve key deliverables including requirements, design outputs, and verification/validation documentation
• Support Regulatory Affairs activities including regulatory submissions, responses to regulatory inquiries, implementation of new or revised standards, and internal/external audits
• Participate in project and design review meetings
• Perform Design Quality activities within the product risk management process, including review and approval of DFMEA and related risk management documentation
• Support Engineering Change Orders (ECOs) with quality assessment and completion of applicable activities
• Provide Design Quality support for design transfer of new products and sustaining changes to Manufacturing, Operations Quality, and Supplier Quality
This is an ideal role for someone with a strong background in medical device design assurance, quality systems, and regulatory compliance who wants to make an impact at a growing healthtech company navigating the PMA pathway.
Requirements: Not specified in posting.
