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.

Required Qualifications

• Bachelor s or Master s degree in Electrical, Mechanical, Computer, or Systems Engineering (or equivalent).
• Minimum 5+ years of hands-on medical device systems engineering experience.
• Demonstrated experience leading New Product Development (NPD) programs through full product lifecycle.
• Strong background in systems architecture, requirements engineering, and cross-disciplinary integration.
• Proven expertise in:
• ISO 14971 Risk Management
• IEC 60601 and ISO 80601 standards
• FMEA leadership
• V-Model development and traceability
• Experience developing electromechanical medical devices integrating hardware and software.

Preferred Qualifications

• INCOSE Certified Systems Engineering Professional (CSEP) certification.
• Experience serving as primary Systems Engineer on commercialized devices.
• Experience supporting regulatory submissions and audit readiness.
• Exposure to model-based systems engineering (MBSE) tools.