System Engineer

Location: New Kensington, PA (Hybrid – 3 days onsite per week)

Employment Type: (6–12 months, with potential conversion to full-time)

We are seeking experienced Systems Engineers to support the design and development of complex electromechanical medical devices. This role involves full product lifecycle ownership, from concept through verification and validation, with a strong emphasis on systems architecture, risk management, and regulatory compliance.

The ideal candidate has deep experience in medical device development, strong systems thinking, and the ability to lead cross‑functional teams across engineering, manufacturing, and regulatory functions.

• Perform system analysis, modeling, and trade studies to identify optimization opportunities and technical risks
• Define and maintain system architectures for electromechanical systems with hardware and software components
• Analyze system requirements and develop detailed system and subsystem specifications
• Serve as a technical authority for complex systems engineering challenges

• Lead systems engineering activities across the full product development lifecycle (concept through launch)
• Apply industry research and emerging technologies to improve system designs
• Introduce and evaluate new systems engineering tools and methodologies
• Support Product Development Lifecycle Management (PLM) processes
• Lead and facilitate FMEAs and hazard analyses
• Decompose and apply medical device standards, including:
• IEC 60601-1-11
• ISO 80601-2-70
• ISO 80601-2-72
• ISO 14971
• Ensure risk 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 strategies, verification protocols, and test plans
• Build and maintain traceability matrices across the V‑model
• Evaluate requirement failures and translate findings into updated subsystem requirements

• Coordinate systems engineering requirements across R&D, Manufacturing, Quality, and Regulatory teams
• Lead technical and design reviews to ensure alignment across functions
• Mentor junior systems engineers on tools, processes, and best practices
• Drive cross‑functional process improvement initiatives using lean methodologies

• Bachelor’s or Master’s degree in Electrical Engineering, Mechanical Engineering, Computer Engineering, Computer Science, or a related field
• 5+ years of experience with a Bachelor’s degree OR 3+ years with a Master’s degree in:
• Hardware or Electromechanical Design
• Significant experience in New Product Development (NPD) across the full product lifecycle
• Proven expertise developing electromechanical medical devices with integrated hardware and software
• Strong knowledge of medical device standards (ISO 14971, IEC 60601 series)
• Experience writing product and element requirements with clear rationale
• Hands‑on experience with FMEA, requirements decomposition, and traceability

• INCOSE CSEP or equivalent systems engineering certification
• Experience with simulation and modeling software
• Familiarity with CI/CD concepts in regulated product development environments
• Experience working in hybrid or cross‑site engineering teams