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# System Engineer

- **Company:** Intellectt, Inc
- **Location:** New Kensington, PA, United States
- **Salary:** $118,800.0 - $132,000.0
- **Contract:** Temporary to permanent
- **Skills:** Systems Engineering, Software Documentation, Computer Engineering, Continuous Integration, Failure Mode Effects Analysis, Requirements Traceability, Systems Architecture
- **Published:** July 3, 2026
- **Apply:** https://www.careerjet.com/jobad/us4ae10d574cf92b25eea86d3c628726aa

## About the Role

* Systems Engineering, Systems Architecture, and Systems Design
 * Medical device standards: ISO 14971 and IEC 60601 series
 * New Product Development and full product lifecycle experience
 * Electromechanical device development with hardware and software elements
 * Requirements analysis and requirements traceability
 * Risk Management and FMEA
 * Verification & Validation planning
 * Regulatory and quality compliance
 * Product Development Lifecycle Management
 * Cross-functional technical leadership
 * Simulation tools, CI/CD, and continuous improvement methodologies
 * Experience in system architecture, system design, hardware engineering, or related areas.
 * Certified Systems Engineering Professional certification.

## Description

The Systems Engineer will lead systems engineering activities for medical device product development, including requirements development, standards decomposition, risk management, FMEA, V&V planning, and traceability across the V-model. The role requires strong experience in electromechanical medical devices with hardware, software, and regulatory compliance responsibilities., * Develop product-level and element-level requirements with clear rationales.

 * Interpret and decompose medical device standards including IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72.
 * Lead deep-dive FMEA activities and translate risk findings into subsystem requirements.
 * Ensure control measures are documented in the Risk Management File and Design History File.
 * Define system-level risks and drive requirements into software, electrical, and mechanical subsystems.
 * Develop V&V protocols, test plans, and traceability matrices across the V-model.
 * Review system documentation and design artifacts for compliance and completeness.
 * Lead technical reviews and align cross-functional teams including R&D, manufacturing, regulatory, and quality.
 * Support process improvements within the systems engineering framework.


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