Systems Engineer-Hybrid

Elyon International•New Kensington, PA

12h•Hybrid

About The Position

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 novel 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. Write Product and Element Requirements along with their rationales for those 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.

Requirements

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.
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.

Nice To Haves

Preferred Certification: Certified Systems Engineering Professional (CSEP)
Product Development Lifecycle Management
Research & Analysis
Quality Specifications
Regulatory Requirements
Requirements Analysis
Business Acumen
Continuous Improvement
Strategic Planning
Systems Architecture
Systems Engineering
Systems Design
Systems Integration
Risk Management
Simulation Software
CI/CD

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 novel 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.
Write Product and Element Requirements along with their rationales for those 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.