Principal Systems Engineer - 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

• Permanent position for a Principal Systems Engineer responsible for architecture, integration, and life cycle technical direction of regulated medical device systems spanning hardware, firmware, and clinical use environments.
• Define and maintain system architectures, system-level requirements, and interface definitions across electrical, mechanical, software, usability, and clinical domains, with traceability maintained through the full product life cycle.
• Lead system integration activities and resolve cross-domain technical issues across development programs.
• Perform hazard analysis and risk management per ISO 14971, including risk evaluations triggered by complaints, nonconformance reports, and production trends.
• Direct verification and validation strategy, including validation per IEC 62366-1 and FDA human factors guidance.
• Provide system-level content for regulatory submissions, including architecture descriptions, risk traces, and verification summaries.
• Review nonconformance reports and deviations, assessing system-level risk and determining the need for design or manufacturing action.
• Support field actions, quality holds, and CAPA investigations requiring system-level technical coordination.
• Serve as technical subject matter expert for Design Controls and systems engineering process during audits and regulatory inspections, and mentor engineers on systems engineering practice.
• BS Engineering (Systems, Biomedical, Electrical, Mechanical, or Software).
• Minimum 10 years of systems engineering or product development experience on complex, regulated products.
• Working knowledge of systems engineering methodology, requirements management, and system architecture development.
• Working knowledge of FDA Design Controls, ISO and IEC environments and usability engineering principles.
• Experience with requirements management, traceability, and model-based systems engineering tools (SysML or equivalent).
• Experience contributing system-level documentation to regulatory submissions.
• Experience with ECO/change control and system-level technical assessment of design updates and deviations.
• Experience with post-market surveillance, complaint trend analysis, field action coordination, and system-level safety assessment.