• Principal Engineer, Software Engineering…

    Robert Half Technology (Mahwah, NJ)


    Description

    Systems Engineer – Medical Device

     

    Employment Type: Contract-61 Weeks

     

    Pay: Available on W2

     

    About the Role

     

    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.

    Key Responsibilities

    Technical Responsibilities

    + 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.

    Requirements

    Business Responsibilities

    + 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.

    Compliance Responsibilities

    + 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.

    General Responsibilities

    + Work independently with stakeholders to ensure project success.

    + Quickly assimilate procedures, policies, processes, and technology.

    + Apply advanced experience to solve complex problems.

    + Demonstrate ownership and prioritize tasks effectively.

    + Collaborate as a key team member to build strong relationships.

    •Technical Skills

    + Working knowledge of requirements and verification practices.

    + Familiarity with requirements management tools.

    + Ability to communicate technical plans and information clearly.

     

    Preferred Skills

     

    + 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.

     

    Certifications

     

    + INCOSE ASEP or equivalent certification preferred.

     

    Education & Experience

     

    + Bachelor’s degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering.

    + Minimum of 2+ years of relevant work experience.

     

    Technology Doesn't Change the World, People Do.®

     

    Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

     

    Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.

     

    All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

     

    • 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .