MM International, LLC · 7 hours ago
Sr. Systems Engineer
Pennsylvania, United States
Contract
Hybrid
Senior Level
5+ years expMM International, LLC is seeking a Sr. Systems Engineer to perform system analyses and modeling to identify optimization opportunities and risks. The role involves coordinating systems engineering requirements across various teams, leading development strategies, and ensuring compliance with engineering standards.
Staffing & Recruiting
Responsibilities
Perform system analyses and modeling to identify optimization opportunities and risks
Apply research and industry trends to improve system designs and approach
Coordinate systems engineering requirements across R&D, manufacturing, and regulatory teams
Review system documentation to ensure compliance with engineering standards and regulations
Lead development and execution of systems engineering strategies; mentor junior engineers
Analyze system requirements and produce detailed design specifications
Introduce, evaluate, and test new systems engineering tools and methodologies
Act as technical authority for complex systems engineering issues and tradeoffs
Lead cross-functional process improvement initiatives using lean methods
Write product and element requirements with clear rationale
Decompose medical device standards (IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72) into actionable requirements
Lead deep-dive FMEAs; evaluate requirement failures and drive subsystem updates
Ensure control measures flow into the Risk Management File (RMF) and Design History File (DHF)
Translate system-level risks into software, electrical, and mechanical requirements
Develop V&V protocols, test plans, and build trace matrices across the V-model
Lead technical reviews to align cross-functional stakeholders
Qualification
Required
Bachelor's or Master's degree in Electrical/Electronic Engineering, Mechanical Engineering, Computer Science Engineering, or equivalent
5+ years with Bachelor's, OR 3+ years with Master's in System Architecture, System Design, Hardware Engineering, or related areas
Significant New Product Development (NPD) experience across the full product life cycle
Proven experience delivering electromechanical devices with hardware + software elements
Strong knowledge of medical device standards, especially ISO 14971 and the IEC 60601 series
CSEP (INCOSE) or Engineering Professional (CSEP) listed as a key credential (include if you have it)
Preferred
Product Development Lifecycle Management, Regulatory Requirements, Quality Specifications
Requirements analysis, systems integration, risk management
Simulation software exposure
CI/CD familiarity (especially where software is part of the device ecosystem)
Continuous improvement mindset, strategic planning, business acumen
Company
MM International, LLC
MM International, LLC | Your Trusted Staffing Partner Across the USA! 🚀 Connecting top talent with unparalleled opportunities nationwide.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase