Senior Software Quality Design Assurance Engineer

The Senior Software Quality Design Assurance Engineer is a pivotal member of the product development and quality teams, responsible for ensuring that all software-embedded firmware, mobile applications, and cloud-based platforms-meets the highest standards of safety, efficacy, and regulatory compliance. This role ensures compliance with global regulatory standards and internal quality policies, driving excellence in software design, cybersecurity, documentation, and risk management.

The engineer will serve as a subject matter expert in software quality, collaborating with cross-functional teams to define, implement, and maintain quality processes throughout the software lifecycle. By maintaining rigorous oversight of documentation, risk management, and change control, the engineer ensures audit readiness and continuous improvement. The role also champions a culture of compliance and accountability, providing training and guidance to engineering and product teams on evolving standards and best practices.

• Lead software design assurance activities from concept through commercialization and post-market surveillance, including change management in sustaining.
• Ensure compliance with FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and other applicable standards.
• Support documentation and readiness for 510(k) submissions and other regulatory filings, including cybersecurity-related deliverables across all platforms.
• Drive software design control and change management processes, including requirements traceability, verification, validation, and risk management. Act as process owner and subject manner expert by coaching and training cross functional team on quality requirements for software development.
• Participate in product development meetings to understand scope and requirements from the SQA perspective.
• Assist with maintenance of cybersecurity labeling for user guides, IFUs, and other documentation to align with regulatory expectations and product-specific requirements.
• Ensure Software elements of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are complete, accurate, and audit ready.
• Manage software quality records and ensure alignment with project scope, timelines, and regulatory expectations.
• Oversee the software change management process and ensure all changes are properly assessed and documented for regulatory, risk, and validation impact.
• Implement and maintain cybersecurity controls in accordance with FDA's latest guidance on premarket submissions.
• Collaborate with development teams to ensure device resiliency, threat modeling, and secure design practices are embedded throughout the lifecycle.
• Support internal audits, FDA inspections, and ISO audits related to cybersecurity, software development and quality assurance.
• Mentor and train engineering teams on software quality processes, standards, and compliance expectations.
• Promote a culture of quality, accountability, and continuous improvement across engineering and product teams.

Education & Experience:

Required:

• Bachelor's degree in Engineering, Computer Science, or related field.
• 5+ years of experience in software quality assurance within the medical device industry.
• Strong knowledge of FDA, IEC, and ISO standards for medical device software, including cybersecurity and risk management requirements.
• Experience with embedded systems, mobile apps, and cloud-based platforms.
• Excellent communication, documentation, and cross-functional collaboration skills.

Preferred:

• ASQ CSQE (Certified Software Quality Engineer)
• Experience with electronic document control systems (such as Grand Avenue Software) for managing quality and development documentation, versioning, and traceability.
• Hands-on use of SBOM (Software Bill of Materials) tools for tracking software components and supporting regulatory submissions.
• Familiarity with Ketryx or similar quality applications that integrate R&D and Quality for medical device software compliance.
• Proven ability to collaborate across teams (R&D, Regulatory, IT, QA) and communicate quality requirements clearly.

Knowledge & Skills:

• Strong analytical, problem-solving, and communication skills for identifying, troubleshooting, and documenting software quality issues.
• Experience with electronic document control systems (e.g., Grand Avenue Software) for managing, versioning, and ensuring traceability of quality and development documentation
• Hands-on use of SBOM (Software Bill of Materials) tools for regulatory compliance, software component tracking, and supporting FDA submissions.
• Familiarity with quality and compliance platforms such as Ketryx or similar applications for automating traceability, risk management, and regulatory documentation workflows.
• In-depth knowledge of FDA, IEC, and ISO standards for medical device software, including 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and current FDA cybersecurity guidance
• Understanding of risk management principles and cybersecurity best practices for medical device software, including threat modeling and secure design.
• Experience supporting 510(k) submissions, including preparation and review of software documentation, risk assessments, and cybersecurity deliverables.
• Proficiency in software testing methodologies: functional, regression, system, integration, user acceptance, and exploratory testing.
• Familiarity with Agile, Scrum, and DevOps methodologies for efficient software development and quality assurance processes.