Senior Systems Engineer, Medical Devices & Architecture

KARL STORZ SE & Co. KG; Durham (NC); On-site; USD 114,000 - 148,000; Full time

Benefits offered by this job

Medical / Dental / Vision

Wellness program

Pet insurance

3 weeks vacation

Parental leave

401(k) match

Flexible Spending Accounts

Job summary

KARL STORZ SE & Co. KG in Raleigh, NC, is seeking a Systems Engineer to lead the design of medical technology systems. You will own system requirements and architecture, guiding integration, verification, and regulatory compliance across the development lifecycle.

We expect 8+ years in a regulated industry, strong engineering fundamentals, and experience with IEC 60601 or similar standards. On-site role with travel; visa sponsorship not offered.

Qualifications

• Degree in Electrical Engineering or a related field (Physics, ECE, CS).
• 8+ years of regulated-industry experience in systems engineering.
• Experience across a full product development lifecycle in a regulated industry.

Responsibilities

• Own top-level system requirements and architecture from user needs.
• Serve as Technical Lead on Product Ownership Team throughout development lifecycle.
• Evaluate system performance and trade-offs among reliability, cost, schedule, safety, and risk.
• Lead system integration, verification planning, and traceability between requirements and tests.
• Coordinate external system testing with compliance bodies (TÜV, UL).
• Support risk analysis, configuration management, Agile activities, and documentation.

Skills

System engineering

System requirements

Architecture

Traceability

Agile development

Technical leadership

Risk analysis

Education

BS in Electrical Engineering

MS in Electrical Engineering

PhD in related field

Job description

KARL STORZ SE & Co. KG in Raleigh, NC, is seeking a Systems Engineer to lead the design of medical technology systems. You will own system requirements and architecture, guiding integration, verification, and regulatory compliance across the development lifecycle.

We expect 8+ years in a regulated industry, strong engineering fundamentals, and experience with IEC 60601 or similar standards. On-site role with travel; visa sponsorship not offered.