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Systems Engineer

Axelon

New Kensington, PA

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JOB DETAILS
SKILLS
Communication Skills, Computer Engineering, Computer Science, Continuous Improvement, Cross-Functional, Detail Oriented, Documentation, Electrical Engineering, Electricity, Electromechanics, Electronic Engineering, Failure Mode and Effects Analysis (FMEA), Hardware Design, ISO (International Organization for Standardization), Industry Standards, Industry/Trade Analysis, International Electro-Technical Commission (IEC), Lean Manufacturing, Manufacturing Requirements, Mechanical Engineering, Medical Equipment, Medical Protocols, Mentoring, Performance Analysis, Performance Reviews, Performance Tuning/Optimization, Problem Solving Skills, Process Improvement, Product Development, Product Lifecycle, Productivity Management, Regulations, Requirements Management, Research & Development (R&D), Risk Management, Simulation, System Architecture, Systems Analysis, Systems Engineering, Systems Reliability, Testing, V&V Testing
LOCATION
New Kensington, PA
POSTED
1 day ago
Job Title: System Engineer (Hybrid)
Location: New Kensington, PA

Job Responsibilities:
  • Conducts in-depth system analyses and performance assessments, leveraging advanced modeling and simulation techniques to identify optimization opportunities and mitigate risks, working under limited supervision.
  • Synthesizes insights from cutting-edge research and industry trends to inform system design decisions and drive continuous improvement initiatives within the systems engineering domain.
  • Acts as a bridge between various functional teams, including R&D, manufacturing, and regulatory affairs, facilitating effective communication and alignment on systems engineering requirements and standards.
  • Reviews and assesses system documentation and design artifacts with rigorous attention to detail, verifying compliance with established systems engineering principles and industry regulations.
  • Leads the formulation and execution of comprehensive systems engineering strategies, ensuring alignment with organizational objectives and industry standards.
  • Mentors and guides junior systems engineers, imparting specialized knowledge and fostering their growth in systems engineering principles and methodologies.
  • Analyzes system requirements and generates detailed design specifications, employing advanced systems engineering techniques to optimize system performance and reliability.
  • Innovates and pilots Client systems engineering methodologies and tools, aiming to enhance efficiency, quality, and agility in system development processes.
  • Serves as a senior technical authority and escalation point for intricate systems engineering challenges, providing expert guidance and problem-solving expertise.
  • Leads cross-functional initiatives to develop and implement process enhancements within the systems engineering framework, leveraging lean methodologies to optimize workflows and maximize productivity.
Requirements:
  • Standards Decomposition: Interpret and decompose medical device standards such as IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72.
  • Lead deep-dive FMEA (Failure Mode and Effects Analysis). Evaluate full and partial failure of requirements and drive those findings into specific subsystem requirements to mitigate risks.
  • Ensure all control measures feed directly into the Risk Management File and the Design History File (DHF), maintaining a submission-ready audit trail through the NPD sprint.
  • Define how system-level risks drive specific requirements into software, electrical, and mechanical subsystems to ensure essential performance.
  • Develop V&V protocols and test plans as needed.
  • Develop trace matrices across and up and down the V-model.
  • Develop technical reviews to align cross-functional teams on the direction.
  • Minimum required Education: Bachelor's / master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.
  • Minimum required Experience: Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent.
Engineering Professional (CSEP)
  • Significant experience in New Product Development (NPD) and can speak to experience through the full product life cycle.
  • Expertise developing electromechanical devices with hardware and software elements.
  • Deep understanding of medical device standards such as ISO 14971 and the 60601 series.

About the Company

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Axelon

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