Design Quality Engineer - SaMD

We are seeking a Design Quality Engineer with strong Medical Device Software / SaMD experience to provide quality oversight for new product development. This role will partner closely with R&D teams throughout software design, development, verification, risk management, and regulatory compliance activities., * Provide Design Quality oversight for Medical Device Software and SaMD products.

• Support software requirements, architecture/design reviews, and design controls.
• Facilitate software risk assessments and maintain risk documentation.
• Review verification activities, test results, code reviews, and software defects.
• Support CAPA, non-conformances, root cause investigations, audits, and regulatory submissions.
• Ensure compliance with IEC 62304, ISO 13485, ISO 14971, 21 CFR Part 11, FDA requirements, and EU MDR.

• 3 5+ years of Medical Device experience.
• Design Quality Engineering.
• SaMD / Medical Device Software.
• Software Design Controls.
• Software Risk Management.
• Verification & Validation.
• IEC 62304, ISO 13485 and ISO 14971.