Senior Manufacturing & Supply Chain Engineer

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.  Noctrix Health is seeking a high-caliber Senior Manufacturing & Supply Chain Engineer to drive our global manufacturing and domestic fulfillment strategy. This is an end-to-end "Cradle-to-Grave" operations role. You will manage our primary suppliers in Asia and secondary partners in the USA, lead technical validations (IQ/OQ/PQ) at supplier sites, and oversee our domestic DME (Durable Medical Equipment) fulfillment and RMA operations. The successful candidate will be a technical operator who can bridge the gap between engineering rigor and supply chain agility. This position reports to the VP of Supply Chain & Operations.   **This is a full-time, in-person role based in Pleasanton, CA.**  Responsibilities:  Serve as the primary lead for Asia-based and USA-based contract manufacturers, managing supplier performance, costs, production schedules, and strategic partnerships  Lead and perform IQ, OQ, and PQ validations at supplier facilities to ensure manufacturing lines meet Noctrix quality and compliance standards  Collaborate with supplier engineers to optimize manufacturing processes, reduce scrap rates, and improve overall yield  Travel internationally (primarily Asia) to conduct supplier audits, oversee production launches, and resolve technical issues on-site  Analyze supplier capacity against sales forecasts to identify bottlenecks and lead long-term manufacturing scale-up planning  Develop and manage global supply and demand models to balance international lead times with domestic demand fluctuations  Execute strategic sourcing and procurement for components and finished goods  Direct daily DME operations to ensure accurate, compliant order fulfillment  Manage and supervise DME technicians, setting priorities for fulfillment and technical work  Design and implement custom tools (automation scripts, advanced trackers, ERP enhancements) to improve operational efficiency and fulfillment throughput  Own the RMA process, performing physical investigations of returned medical devices to identify root causes and failure modes  Provide closed-loop feedback to supplier engineers and internal R&D teams to drive continuous product and process improvement  Requirements:  7+ years in Supply Chain or Operations within the Medical Device (ISO 13485/FDA) industry  Hands-on experience with IQ/OQ/PQ and manufacturing process validation  Proven experience managing Asia-based contract manufacturers and navigating global logistics  Experience in a DME environment using order fulfillment and shipping tools.  Strong ability to build/enhance tools (Advanced Excel/VBA, SQL, or Low-code platforms) to automate workflows  Bachelor’s degree in Engineering (Mechanical, Industrial, or Electrical) or a related technical field is strongly preferred  Must be able to work at the office at least three days a week  Preferred:  Deep understanding of DMEPOS quality standards.  Experience in Lean Manufacturing or Six Sigma (Green/Black Belt) Ability to troubleshoot hardware and perform root-cause analysis Compensation:  Base pay: $125,000–$150,000 per year + bonus Offices: Pleasanton, California, United States (Pleasanton - HQ);