Systems Engineer, Robert Half

Robert Half

Location:
United States, Mahwah

Category:
IT - Software Development

Contract Type:
Contract work

Salary:

Not provided

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Job Description:

We are seeking a Systems Engineer to join our team and help establish a robust design control and risk management structure for implant and instrument systems. This role focuses on applying a systems engineering approach to medical device development, ensuring compliance with industry standards and regulatory requirements. You will collaborate closely with engineering teams to develop architecture documents, use cases, and requirement tiering strategies. Additionally, you will assist in transitioning legacy design controls to a modern, integrated structure and implement these processes within Jama requirements management software.

Job Responsibility:

Research, design, develop, modify, and verify medical device systems
Translate user needs into system requirements
Create and refine system architectures and test designs
Contribute to design decomposition using modeling, simulation, budgeting, and mathematical techniques
Support product risk management activities
Develop system architecture for joint replacement instrumentation design controls and risk management
Translate legacy requirements into new requirements for consolidated design controls
Demonstrate advanced understanding of customer needs and design inputs
Gain proficiency in product intended use and clinical procedures
Learn financial model structures related to product development
Follow industry standards, design requirements, and test strategies aligned with regulatory requirements
Independently create or refine engineering documentation (e.g., Design History File)
Adhere to R&D procedures such as design controls and risk management per the Quality Management System

Requirements:

Bachelor's degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering
Minimum of 2+ years of relevant work experience
Working knowledge of requirements and verification practices
Familiarity with requirements management tools
Ability to communicate technical plans and information clearly
INCOSE ASEP or equivalent certification preferred

Nice to have:

Experience with Jama or similar requirements management software
Knowledge of SysML and Model-Based Systems Engineering (MBSE)
Familiarity with ISO 13485 and ISO 14971 standards

What we offer:

Medical, vision, dental, and life and disability insurance
401(k) plan
Free online training

Additional Information:

Job Posted:
November 11, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Systems Engineer