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.