Sr Principal Software Design Quality Engineer

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The Senior Principal Engineer, Software Design Quality serves as a senior technical authority for software design quality and design assurance throughout the product lifecycle. This position provides independent Quality leadership to ensure software and software-intensive medical devices are developed, verified, validated, released, and maintained in accordance with applicable design controls, software lifecycle processes, risk management requirements, regulatory requirements, and the Quality Management System.

The primary focus is embedded software used in electromechanical medical devices, with potential future support for PC-based, web-based, connected, or interoperable software.

The Senior Principal Engineer partners with Software Engineering, Systems Engineering, Product Security, Human Factors, Regulatory Affairs, Medical/Clinical, Manufacturing, Post-Market Quality, and other functions to establish appropriate quality strategies and ensure that software product risks are identified[GC1.1][SF1.2], understood, controlled, and supported by objective evidence. The role operates with a high degree of independence and is expected to influence technical and quality strategy across programs and product platforms.

As the senior Software Design Quality representative, the individual is expected to make and defend difficult quality, safety, compliance, and release decisions with limited day-to-day supervision. The work will frequently involve iterative software releases, defect corrections, sustaining changes, and significant updates to existing requirements, traceability, and risk-management documentation in addition to traditional new-product development. The Senior Principal Engineer applies advanced engineering judgment to complex or ambiguous issues, challenges assumptions constructively, identifies systemic risks, and drives technically sound solutions that support safe, effective, reliable, and compliant medical devices.

• Serve as the senior Design Quality technical authority for medical device software projects across the full product lifecycle.
• Provide Design Quality oversight primarily for embedded software used in electromechanical medical devices, with the ability to support PC-based, web-based, connected, and interoperable software as product needs evolve.
• Provide independent Quality leadership for software development, sustaining engineering, design changes, and release decisions.
• Operate independently and make risk-based quality decisions with limited day-to-day supervision from geographically dispersed teams.
• Establish risk-based software Design Quality strategies aligned with intended use, product architecture, development methodology, and regulatory expectations.
• Demonstrate understanding of and ensure adherence to applicable FDA regulations, ISO and IEC standards, design controls, software lifecycle processes, and Quality System requirements within the area of responsibility and expertise.
• Effect positive change on internal processes to improve team efficiency while maintaining the highest quality standards Provide Quality oversight of software lifecycle plans and deliverables from concept and planning through development, release, maintenance, and retirement.
• Lead Quality oversight of iterative software releases, sustaining changes, defect corrections, cybersecurity updates, and significant revisions to software requirements, traceability, and risk-management documentation.
• Evaluate software requirements for completeness, clarity, consistency, testability, allocation, and linkage to user needs and system requirements.
• Ensure end-to-end traceability among requirements, architecture, risk controls,…