Senior Systems Engineer - Imaging Software Lead

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

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