Risk Management (Medical Devices)

<div class="content-intro"><p>We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more.</p> <p>As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing.</p> <p>When you join ALTEN Technology USA, you’ll collaborate on some of the world’s toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.</p></div><p></p> <p><strong>Position Summary</strong></p> <ul> <li>We are seeking a <strong>Risk Management Subject Matter Expert (SME)</strong> with extensive experience in medical device risk management and a solid background in <strong>Systems Engineering</strong>.</li> <li>The consultant will support the <strong>development, review, and technical assessment</strong> of key risk management deliverables for the medical device program.</li> </ul> <p><strong>Key Responsibilities</strong></p> <ul> <li><strong>Development and Review of Key Risk Management Deliverables</strong></li> <li>Conduct the&nbsp;<strong>technical review of the PHA.</strong></li> <li>Support the&nbsp;<strong>development and technical review</strong> of the BE CT CHA and platform CHA, including associated platform risk libraries:</li> <li>Ensure alignment with Systems Engineering deliverables (e.g., consistency between RCMs and design inputs).</li> <li>Verify alignment of risks and RCMs with applicable standards (e.g., <strong>ISO 11608</strong>, <strong>IEC 60601‑1</strong>, etc.).</li> <li>Support integration activities related to platform risk libraries.</li> <li><strong>Support for Additional Risk Management Deliverables</strong></li> <li>Contribute to the&nbsp;<strong>development and review of the Platform Risk Management Plan (RMP)</strong>.</li> <li>Participate in&nbsp;<strong>Functional Failure Analysis</strong>, including:</li> <li>Identification of system-level effects.</li> <li>Assignment of appropriate defect classifications.</li> <li>Support additional Risk Management deliverables as required throughout the project lifecycle.</li> <li>Reviewing an