System Engineer IV

Karl Storz Endoscopy; Durham (NC); Hybrid; USD 114,000 - 148,000; Full time

Job summary

KARL STORZ Endoscopy in Raleigh, NC, is seeking an experienced Systems Engineer to lead system-level design for medical imaging technology. You will own system requirements, architecture, and verification, and serve as technical lead on the Product Ownership Team alongside Project and Product Management.

On-site role with national/international travel. Ideal applicants hold an advanced degree in engineering or related field and have 8+ years of regulated-industry experience with strong software

Qualifications

• 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, 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.

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 TUV and UL.
• Support system risk analysis, configuration management, Agile development activities, sustaining engineering, and documentation of system changes.

Skills

System requirements

System architecture

Product ownership

Regulated-industry experience

Test planning & verification

Risk analysis

Documentation

Cross-functional leadership

Education

BS/MS/PhD in Electrical Engineering or related field

Job description

About KARL STORZ

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 MedTech 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.

About the Role

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.

What You'll Do

• 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 TUV and UL.
• Support system risk analysis, configuration management, Agile development activities, sustaining engineering, and documentation of system changes.

What You Bring

• 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.

What Will Make You Successful

• 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.

Why KARL STORZ?

Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you'll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide.