Senior Principal Medical Device Systems Engineer

Abbott Laboratories seeks a Senior Principal Engineer to lead the design and development of advanced medical devices and diagnostic technologies. In this senior technical role, you will own system architecture, guide complex design decisions, and ensure compliance with FDA, ISO 13485, and global regulatory standards. You will collaborate across R&D, quality, regulatory, and manufacturing, mentor engineers, and drive innovation that improves health and quality of life worldwide in a mission-driven, inclusive culture with strong career growth opportunities.

Responsibilities

• Serve as principal technical authority for complex medical device and diagnostic systems
• Lead end-to-end product development from concept through verification, validation, and launch
• Define system architecture and drive key design decisions for safety, reliability, and performance
• Ensure compliance with FDA, ISO 13485, and other global regulatory and quality standards
• Collaborate with R&D, quality, regulatory, manufacturing, and clinical teams to deliver solutions
• Mentor and guide engineers, fostering a culture of technical excellence and innovation
• Use data-driven methods and risk management tools to optimize design and reduce defects
• Represent engineering in strategic planning, technology roadmapping, and portfolio decisions
• Drive continuous improvement in development processes, tools, and design best practices
• Support global customers and internal stakeholders with high-level technical problem solving

Required Skills

• Medical device or diagnostics product development
• Systems engineering and architecture
• FDA and ISO 13485 regulatory compliance
• Risk management (FMEA, fault tree analysis)
• Design verification and validation
• Statistical analysis and design of experiments
• Requirements management and traceability tools
• Technical leadership and mentoring
• Cross-functional project collaboration
• Quality systems and design controls