Systems Engineer

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.