Principal Systems Engineer: Regulated Medical Devices

Engineering Resource Group, Inc.; Clifton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

Engineering Resource Group, Inc. seeks a Principal Systems Engineer to lead architecture, integration, and life cycle direction of regulated medical device systems spanning hardware, firmware, and clinical use environments.

You will define architectures and interfaces, drive MBSE and traceability across domains, perform risk management per ISO 14971, and contribute to regulatory submissions while mentoring engineers and coordinating cross-functional teams.

Qualifications

• BS in Engineering (Systems/Biomedical/Electrical/Mechanical or Software).
• Minimum 10 years of systems engineering or product development on complex, regulated devices.
• Experience with FDA Design Controls, ISO/IEC environments, and usability engineering.
• Experience with requirements management, traceability, and model-based systems engineering.

Responsibilities

• Define and maintain system architectures, system-level requirements, and interfaces across domains.
• Lead system integration activities and resolve cross-domain technical issues.
• Perform hazard analysis and risk management per ISO 14971.
• Direct verification and validation per IEC 62366-1 and FDA usability guidance.
• Provide system-level content for regulatory submissions.
• Mentor engineers on systems engineering practice during audits.

Skills

Systems engineering

Regulatory compliance

Requirements management

Traceability

Model-based systems engineering

FDA Design Controls

Risk management

Regulatory submissions

Leadership / mentoring

Cross-domain coordination

Education

BS Engineering (Systems/ Biomedical/ Electrical/ Mechanical/ Software)

Tools

SysML

DOORS

MBSE

Job description

Engineering Resource Group, Inc. seeks a Principal Systems Engineer to lead architecture, integration, and life cycle direction of regulated medical device systems spanning hardware, firmware, and clinical use environments.

You will define architectures and interfaces, drive MBSE and traceability across domains, perform risk management per ISO 14971, and contribute to regulatory submissions while mentoring engineers and coordinating cross-functional teams.