MBSE Systems Design Engineer - Medical Devices (Hybrid)

Joulé; Mahwah (NJ); Hybrid; USD 62,000 - 76,000; Part time

Job summary

Joulé in Mahwah, NJ is seeking a Systems Design Engineer to support design, development, and implementation of medical device systems and software. The role emphasizes a structured, traceable design control framework using Jama and related tools to ensure compliance, quality, and efficient verification and validation processes.

The engineer will follow the SDLC, collaborate with cross-functional teams, and establish a design control and risk management structure for implant instruments.

Qualifications

• Bachelor’s degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering.
• 2 years of experience in Systems Engineering, Requirements Management, or Risk Management roles.
• Demonstrated understanding of requirements hierarchy, traceability, and design control processes.

Responsibilities

• Follow the company’s software development lifecycle to design, code, configure, test, debug, and document applications and systems.
• Review functional requirements, analysis, and design documents; provide technical feedback and recommendations.
• Develop and maintain technical design specifications, architecture documents, and system-level documentation.
• Collaborate with cross-functional engineering teams to define system architecture, requirements, and use cases.
• Establish a new implant and instrument design control and risk management structure using a systems engineering approach.
• Create and maintain requirement hierarchies, traceability matrices, and verification/validation documentation in Jama.
• Translate legacy design controls into the new structured system and ensure seamless integration.
• Apply systems engineering techniques such as traceability, architecture modeling, trade studies, simulations, and budgeting.
• Lead or contribute to design verification efforts and integration of systems into final product solutions.
• Participate in design and code reviews to ensure quality and consistency.

Skills

Systems Engineering

Requirements Management

Traceability

Education

Bachelor's degree in engineering

Tools

Jama Connect

Integrity

DOORS

Polarion

SysML / MBSE tools (Cameo/MagicDraw/EA)

Enterprise Architect

Job description

Joulé in Mahwah, NJ is seeking a Systems Design Engineer to support design, development, and implementation of medical device systems and software. The role emphasizes a structured, traceable design control framework using Jama and related tools to ensure compliance, quality, and efficient verification and validation processes.

The engineer will follow the SDLC, collaborate with cross-functional teams, and establish a design control and risk management structure for implant instruments.