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. RAM#

Pay:

$65.00 - $84.00 per hour

Experience:

Medical Device:

5 years (Preferred)

New Product Development:

5 years (Preferred) Systems engineering: 4 years (Preferred)

License/Certification:

CSEP (Preferred)

Work Location:

Hybrid remote in New Kensington, PA 15068