<p><strong>Engineer, R& D Packaging</strong></p><p><strong>Location:</strong> Fremont, CA (Onsite)</p><p><strong>Contract Duration:</strong> 52 Weeks</p><p><strong>About the Role</strong></p><p>We are seeking an <strong>Engineer, R& D Packaging</strong> to join our Sustaining Packaging team. This role focuses on the design and development of packaging components and artwork, design verification, shelf-life testing, and label design for sterile and non-sterile medical devices.</p><p><strong>Key Responsibilities</strong></p><ul><li>Develop and sustain best-in-class packaging and labeling solutions from concept through commercialization.</li><li>Drive continuous improvement initiatives and incorporate Voice of the Customer feedback.</li><li>Create packaging and labeling components that enhance customer experience, including 3D models and artwork.</li><li>Deliver high-quality outputs throughout the development life cycle.</li><li>Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory, Clinical, Marketing, R& D, Supply Chain, and vendors across global locations.</li><li>Ensure compliance with quality requirements and lead improvements to maintain regulatory standards.</li><li>Support audits, non-conformances, and CAPAs as needed.</li><li>Lead small-scale packaging/labeling projects or co-manage large-scale programs.</li><li>Mentor or supervise technical staff when required.</li><li>Manage a varied workload and meet tight timelines with a high level of professionalism.</li></ul>

<p><strong>Basic Qualifications</strong></p><ul><li>Bachelor’s degree in Packaging, Industrial, Mechanical Engineering, or a related technical field.</li><li>0–2 years of experience in a highly regulated industry.</li></ul><p>•<strong>Preferred Qualifications</strong></p><ul><li>Experience in medical device, biotech, or pharmaceutical packaging design and development.</li><li>Ability to resolve design and process-related packaging issues on commercial products.</li><li>Knowledge of Design Controls and industry standards (ISO 11607, ASTM, ISTA).</li><li>Familiarity with database-driven labeling systems and IFU development.</li><li>Proficiency in statistical analysis and interpretation of results.</li><li>Strong interpersonal and communication skills.</li><li>Technical and project management capabilities to deliver projects on time and within budget.</li></ul><p> <strong>Work Environment</strong></p><p>This is an <strong>onsite role</strong> based in Fremont, CA. Candidates should be comfortable working in a collaborative, fast-paced environment.</p>

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