SSi People · 23 hours ago
System Engineer
New Kensington, PA
Contract
Hybrid
Senior Level
$70/hr - $80/hr
5+ years expSSi People is seeking a System Engineer to conduct in-depth system analyses and performance assessments while driving continuous improvement initiatives within the systems engineering domain. The role involves leading comprehensive systems engineering strategies, mentoring junior engineers, and ensuring compliance with industry regulations and standards.
Human ResourcesInformation TechnologyIT ManagementLinuxProfessional ServicesSoftwareStaffing Agency
Hiring Manager
Rashmita Pradhan
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
Qualification
Required
Bachelor's / master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent
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
Preferred
Certified Systems 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
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
Company
SSi People
SSi People, located in Cranberry Township, PA, is an organization with over 25 years of staffing industry experience across various labor verticals in the United States, serving Fortune 1000 companies.
51-200 employees
H1B Sponsorship
SSi People has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (6)
Funding
Current Stage
Growth StageRecent News
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