System Engineer IV

KARL STORZ • Durham, NC

7d • $113,900 - $148,100 • Onsite

About The Position

The Systems Engineer will lead product design at the system level for KARL STORZ’s Asensus entity, which focuses on imaging software. Based in Raleigh, North Carolina, the role ensures complex medical technology meets customer, manufacturing, service, market, safety, and regulatory requirements. The engineer owns system requirements and architecture, guides product integration and verification, and acts as the technical lead on the Product Ownership Team alongside Project and Product Management. The position is on-site and includes occasional national and international travel. It is not eligible for current or future employment visa sponsorship.

Requirements

• BS, MS, or PhD in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science, or a related field.
• 8+ years of regulated-industry experience, including 5+ years as a Systems Engineer or in a similar role.
• Experience across the product development lifecycle in a highly regulated industry.
• Solid understanding of software-design methodologies and deliverables, safety methodologies such as IEC 60601 or similar standards, and microprocessor-controlled systems.
• Broad understanding of analog and digital hardware design, with general knowledge of optical and mechanical design.
• Expert-level ability to document and communicate system engineering and design deliverables.
• Strong analytical thinking, complex problem-solving, critical thinking, and decision-making capabilities.
• Excellent written and verbal communication, stakeholder management, collaboration, and organizational skills.
• Ability to evaluate system architectures, integration methods, performance trade-offs, technical risks, and changes in scope.
• Strategic thinking, creativity, innovation, and the ability to mentor others.

Nice To Haves

• Experience designing medical systems or similarly complex systems.
• Knowledge of medical-device quality standards and regulations, image-acquisition systems, image-processing techniques, communications networks, and complex-system testing.

Responsibilities

• Own top-level system requirements and system architecture, translating user needs into defined and approved product requirements.
• Serve as Technical Lead on the Product Ownership Team and guide system-level design decisions throughout the development lifecycle.
• Evaluate system performance and conduct trade-off analyses involving reliability, cost, schedule, manufacturability, safety, and technical risk.
• Lead system integration and test planning, review verification plans and procedures, and confirm traceability between requirements and verification testing.
• Coordinate external system testing with Compliance Engineering and notified bodies such as TÜV and UL.
• Support system risk analysis, configuration management, Agile development activities, sustaining engineering, and documentation of system changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior