System Engineer IV

At KARL STORZ, we take pride in helping patients through some of the toughest journeys of their lives. We are making contributions that matter. Regardless of your role, YOU improve patients’ lives every day.

From the operating room to surgery centers - and everywhere in between - KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging-to build a more connected, software-enabled operating room. As an independent, family-owned Med Tech company, we ambitiously think in generations instead of quarters to improve patients’ lives around the world.

The following opportunity is to join our Asensus entity which is focused on imaging software.

As a Systems Engineer based in Raleigh, NC, you’ll lead product design at the system level and help ensure complex medical technology meets customer, manufacturing, service, market, safety, and regulatory requirements. You’ll own system requirements and architecture, guide product integration and verification, and serve as the technical lead on the Product Ownership Team alongside Project and Product Management. The compensation range for this position is $113,900 to $148,100.

Additionally, this role is on-site and includes occasional national and international travel.

This position is not eligible for current or future employment visa sponsorship.

• 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.

• 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.
• Experience designing medical systems or similarly complex systems is preferred.
• Knowledge of medical-device quality standards and regulations, image-acquisition systems, image-processing techniques, communications networks, and complex-system testing is preferred.
• Strategic thinking, creativity, innovation, and the ability to mentor others.

Join KARL STORZ and be part of a team…