<p><strong>Systems Engineer – Medical Device</strong></p><p><strong>Location:</strong> Mahwah, NJ</p><p><strong>Employment Type:</strong> Contract-61 Weeks</p><p><strong>Pay: </strong>Available on W2 </p><p><strong>About the Role</strong></p><p>We are seeking a <strong>Systems Engineer</strong> 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 <strong>systems engineering approach</strong> to medical device development, ensuring compliance with industry standards and regulatory requirements.</p><p>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 <strong>Jama requirements management software</strong>.</p><p><strong>Key Responsibilities</strong></p><p><strong>Technical Responsibilities</strong></p><ul><li>Research, design, develop, modify, and verify medical device systems.</li><li>Translate user needs into system requirements.</li><li>Create and refine system architectures and test designs.</li><li>Contribute to design decomposition using modeling, simulation, budgeting, and mathematical techniques.</li><li>Support product risk management activities.</li><li>Develop system architecture for joint replacement instrumentation design controls and risk management.</li><li>Translate legacy requirements into new requirements for consolidated design controls.</li></ul>

<p><strong>Business Responsibilities</strong></p><ul><li>Demonstrate advanced understanding of customer needs and design inputs.</li><li>Gain proficiency in product intended use and clinical procedures.</li><li>Learn financial model structures related to product development.</li></ul><p><strong>Compliance Responsibilities</strong></p><ul><li>Follow industry standards, design requirements, and test strategies aligned with regulatory requirements.</li><li>Independently create or refine engineering documentation (e.g., Design History File).</li><li>Adhere to R& D procedures such as design controls and risk management per the Quality Management System.</li></ul><p><strong>General Responsibilities</strong></p><ul><li>Work independently with stakeholders to ensure project success.</li><li>Quickly assimilate procedures, policies, processes, and technology.</li><li>Apply advanced experience to solve complex problems.</li><li>Demonstrate ownership and prioritize tasks effectively.</li><li>Collaborate as a key team member to build strong relationships.</li></ul><p>•<strong>Technical Skills</strong></p><ul><li>Working knowledge of requirements and verification practices.</li><li>Familiarity with requirements management tools.</li><li>Ability to communicate technical plans and information clearly.</li></ul><p><strong>Preferred Skills</strong></p><ul><li>Experience with <strong>Jama</strong> or similar requirements management software.</li><li>Knowledge of <strong>SysML</strong> and <strong>Model-Based Systems Engineering (MBSE)</strong>.</li><li>Familiarity with ISO 13485 and ISO 14971 standards.</li></ul><p> <strong>Certifications</strong></p><ul><li>INCOSE ASEP or equivalent certification preferred.</li></ul><p><strong>Education & Experience</strong></p><ul><li>Bachelor’s degree in Software, Electrical, Mechanical, Systems, or Biomedical Engineering.</li><li>Minimum of <strong>2+ years of relevant work experience</strong>.</li></ul>

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