System Engineer IV

KARL STORZ

. Lead product design at the system level .

Posted 10/30/2026full-timeRaleigh • North Carolina • United StatesSeniorLead💰 $113,900 - $148,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in system-level product design and integration within regulated industries, with a strong focus on safety, compliance, and performance evaluation. Proficient in translating user needs into product requirements while leading cross-functional teams through the product development lifecycle.

Highest-signal resume keywords

Systems EngineeringMedical Device Quality StandardsAgile DevelopmentSafety MethodologiesProduct Development Lifecycle

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

System RequirementsSystem ArchitectureSoftware-Design MethodologiesAnalog Hardware DesignDigital Hardware DesignMicroprocessor-Controlled SystemsVerification TestingRisk AnalysisTrade-Off AnalysisDocumentation of Engineering Deliverables

Soft Skills

Analytical ThinkingComplex Problem-SolvingDecision-MakingWritten CommunicationStakeholder Management

Tools & Technologies

IEC 60601Image-Acquisition SystemsImage-Processing TechniquesCompliance EngineeringConfiguration Management

Industry Keywords

Regulated Industry ExperienceMedical Systems DesignSystem IntegrationTechnical Risk ManagementManufacturability

About the role

Key responsibilities & impact

Lead product design at the system level
Ensure complex medical technology meets customer, manufacturing, service, market, safety, and regulatory requirements
Own system requirements and architecture
Translate user needs into defined and approved product requirements
Serve as Technical Lead on the Product Ownership Team
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
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
Travel occasionally nationally and internationally

Requirements

What you’ll need

BS, MS, or PhD in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science, or a related field
8+ years of regulated-industry experience
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
Knowledge of safety methodologies such as IEC 60601 or similar standards
Knowledge of microprocessor-controlled systems
Broad understanding of analog and digital hardware design
General knowledge of optical and mechanical design
Expert-level ability to document and communicate system engineering and design deliverables
Experience designing medical systems or similarly complex systems preferred
Knowledge of medical-device quality standards and regulations, image-acquisition systems, image-processing techniques, communications networks, and complex-system testing preferred
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 ability to mentor others
Must be able to work on-site
This position is not eligible for current or future employment visa sponsorship

Benefits

Comp & perks

Medical / Dental / Vision including a state-of-the-art wellness program
Access to pet insurance
3 weeks vacation accrual for full time roles
Paid holidays
Paid sick time
Up to 8 weeks of 100% paid company parental leave, including maternal/paternal leave, adoption, and fostering of a child
401(k) retirement savings plan with a match of 66.67% (4%) of the employee’s first 6% contribution, up to IRS limits
Section 125 Flexible Spending Accounts
HSA Savings Accounts with company contribution
Life, STD & LTD Insurance
Tuition prepaid up to $5,250 per year
Fitness reimbursement of up to $200 annually