System Engineer

Job Title : System Engineer

Duration : 12 Months

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

Position Overview

We are seeking a hands-on Systems Engineer with direct medical device new product development experience who has served as a primary systems lead—not solely in a quality or support capacity.

The ideal candidate will be a broad technical systems thinker with demonstrated ownership of system architecture, risk management, and standards compliance throughout the full product lifecycle.

Candidates must have recent medical device industry experience and a stable employment history reflecting sustained contributions to device development programs.

Key Responsibilities

• Lead end-to-end systems engineering activities for medical device new product development programs.
• Develop and document Product and Element Requirements with clear technical rationales .
• Perform standards decomposition of IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72 , translating regulatory requirements into actionable subsystem requirements.
• Lead deep-dive FMEA activities and system-level risk management (ISO 14971) .
• Ensure all risk controls and mitigations are properly documented within the Risk Management File (RMF) and Design History File (DHF) .
• Develop and maintain traceability matrices across the V-model , ensuring bidirectional requirement flow-down and verification alignment.
• Define how system-level risks propagate into software, electrical, and mechanical subsystem requirements .
• Develop comprehensive Verification & Validation (V&V) strategies, protocols, and test plans .
• Serve as technical lead across R&D, manufacturing, regulatory, and quality teams to drive alignment.
• Mentor junior engineers in systems methodology and best practices.