Senior Systems Engineer – Medical Devices & Risk Management

Elyon International; New Kensington (Westmoreland County); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Paid sick leave

Medical/Dental (optional)

401(k) Retirement Plan (optional)

Employer Paid Life Insurance

Employer Paid Short Term Disability

Optional Life Insurance

Job summary

Elyon International is seeking a senior Systems Engineer to lead design, analysis, and risk management across software, electrical, and mechanical subsystems. You will drive NPD activities, mentor engineers, and ensure compliance with IEC 60601-1/11 and ISO 80601-2-series standards while coordinating across R&D, manufacturing, and regulatory teams.

The role emphasizes rigorous documentation, requirements tracing, and V-model validation to deliver robust, compliant medical devices within

Qualifications

• Bachelor's or Master's degree in electrical/electronic/mechanical engineering or equivalent.
• Minimum 5 years of experience in System Architecture, System Design, or Hardware Engineering; 3+ years with a Master's.
• Certified Systems Engineer (CSEP) preferred and ISO/IEC knowledge.
• Experience with New Product Development (NPD) lifecycle and medical device standards.

Responsibilities

• Analyze system requirements and develop detailed design specifications.
• Lead FMEA and drive subsystem requirements to mitigate risks.
• Develop V&V plans and ensure traceability across the V-model.
• Mentor junior engineers and coordinate cross-functional teams.
• Ensure documentation feeds into Risk Management File and DHF.
• Define system-level risks driving requirements for subsystems (software/hardware/mechanical).
• Develop standards decomposition for IEC/ISO medical device guidelines.
• Drive continuous improvement through lean methodologies and cross-functional reviews.

Skills

Systems Engineering

Risk Management

FMEA

Regulatory Compliance

Lean Methodologies

Cross-functional Leadership

Mentoring

Requirements Analysis

Design Verification

Education

Bachelor's or Master's in Electrical/Mechanical/Computer Science Engineering

Minimum 5 years experience in System Architecture/Design or Hardware Engineering

Certified Systems Engineer (CSEP)

Tools

Simulation Software

V-Model Traceability

Job description

Elyon International is seeking a senior Systems Engineer to lead design, analysis, and risk management across software, electrical, and mechanical subsystems. You will drive NPD activities, mentor engineers, and ensure compliance with IEC 60601-1/11 and ISO 80601-2-series standards while coordinating across R&D, manufacturing, and regulatory teams.

The role emphasizes rigorous documentation, requirements tracing, and V-model validation to deliver robust, compliant medical devices within