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System Engineer

Intellectt INC

New Kensington, PA

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JOB DETAILS
SKILLS
Computer Engineering, Continuous Deployment/Delivery, Continuous Improvement, Continuous Integration, Cross-Functional, Documentation, Electricity, Electromechanics, Failure Mode and Effects Analysis (FMEA), Hardware Design, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Manufacturing Requirements, Medical Equipment, Medical Products, Medical Protocols, Process Improvement, Product Development, Product Lifecycle, Product Lifecycle Management, Regulatory Compliance, Regulatory Compliance Software, Requirements Management, Research & Development (R&D), Risk, Risk Management, Simulation, System Architecture, Systems Engineering, Technical Leadership, Testing, Traceability, V&V Testing, Validation Plan, Verification Plans
LOCATION
New Kensington, PA
POSTED
3 days ago

Job Title: Systems Engineer
Location: Pennsylvania, USA
Duration: 11 Months

Job Summary:
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.

Key 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.

Skills Required:

  • 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.

For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.

About the Company

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Intellectt INC