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Systems Engineer – Contract Location: New Kensington, PA Schedule: Hybrid, 3 days onsite | 40 hrs/week Contract: 1/23/2026 – 1/22/2027 Openings: 8 Local to Pennsylvania required We’re seeking experienced Systems Engineers for a long-term hybrid contract supporting complex medical device product development. This role is ideal for someone who can lead systems-level analysis, translate standards into requirements, support risk management, and collaborate across software, electrical, mechanical, R&D, manufacturing, and regulatory teams. What You’ll Do • Develop product, element, and subsystem requirements with clear rationales • Decompose medical device standards including IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72 • Lead FMEA activities and connect risks to specific system and subsystem requirements • Support Risk Management File and Design History File documentation • Build trace matrices across the V-model • Develop V&V protocols, test plans, and technical reviews • Partner cross-functionally to drive systems engineering strategy and process improvements Requirements • Bachelor’s degree with 5+ years of experience, or Master’s degree with 3+ years of experience • Background in systems architecture, systems design, hardware engineering, or related engineering work • Experience with electromechanical devices involving hardware and software • Strong understanding of medical device standards, risk management, and product development lifecycle • NPD / full product lifecycle experience strongly preferred • CSEP certification preferred This is a strong opportunity for a senior systems engineering professional who enjoys solving complex technical challenges in a regulated medical device environment. Contact us today for more details job.com is an Equal Opportunity employer