<p>Join a high-impact team driving innovation in medical device development—where your expertise in software and hardware quality engineering will directly shape the future of healthcare technology.</p><p><br></p><p><strong>Schedule & Location:</strong></p><ul><li><strong>Hours:</strong> 8:00 AM – 5:00 PM (Pacific Time)</li><li><strong>Work Setup:</strong> Hybrid preferred (3 days/week onsite or as needed)</li><li>Local candidates preferred</li><li>Open to remote with occasional travel to site</li></ul><p><strong>Employment Type:</strong></p><ul><li>Contract with <strong>possibility of extension</strong></li><li><strong>Temp-to-hire</strong> potential</li></ul><p><strong>Job Description</strong></p><p>Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with regulatory standards and driving quality throughout the product lifecycle.</p><p><strong>Essential Duties & Responsibilities</strong></p><p><strong>Primary Responsibilities:</strong></p><ul><li>Lead design control, risk management, and other quality engineering activities for new product development.</li><li>Develop and maintain Risk Management Files (RMF): risk plans, hazard analysis, dFMEAs, pFMEAs, and reports.</li><li>Review and approve Design History File (DHF) documentation.</li><li>Oversee product development plans, design inputs/outputs, verification/validation, and test protocols/reports.</li><li>Guide statistical methods and analyses for design verification and validation.</li><li>Act as SME for software quality: code reviews, software security analysis, software BOM, and best practices.</li><li>Participate in design reviews for hardware/software lifecycle management.</li><li>Support production transfer and post-deployment phases.</li><li>Address anomalies (e.g., bugs, cybersecurity issues) and guide remediation.</li></ul><p><strong>Secondary/Backup Responsibilities:</strong></p><ul><li>Lead updates to the Quality System based on new regulations and standards.</li><li>Own CAPA resolution related to design control.</li><li>Support released products and interface with customer support.</li><li>Assist other Quality System areas as needed.</li></ul>

<p><strong>Qualifications</strong></p><p><strong>Required:</strong></p><ul><li>8+ years of progressive Quality Engineering experience in the <strong>medical device industry</strong>.</li><li>Hands-on support for <strong>hardware and software development</strong>.</li><li>Strong knowledge of:</li><li>FDA CFR 820</li><li>ISO 13485, ISO 14971</li><li>IEC 60601 series, IEC 62304, IEC 62366</li><li>Experience with:</li><li>Design, development, verification, validation, and testing of medical devices</li><li>Statistical tools and data analysis</li><li>Excellent communication and presentation skills</li><li>Ability to manage multiple projects and advocate for quality</li><li>Proficient in Microsoft Office, Adobe Acrobat, Minitab, and other business software</li></ul><p><strong>Preferred:</strong></p><ul><li>ASQ CQE certification and/or Six Sigma Black Belt/Green Belt</li><li>Experience with:</li><li>Artificial Intelligence (AI) and AAMI TIR45 framework</li><li>Software as a Medical Device (SaMD)</li><li>Cloud infrastructure</li></ul><p><strong>Education:</strong></p><ul><li>B.S./M.S. in Engineering (Biomedical, Software, Electrical, etc.) or equivalent scientific degree</li></ul><p><br></p>

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