I&A Manufacturing Lead II Job San Jose area,California USA,Manufacturing / Production

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Job Function

Supply Chain Manufacturing

Job Sub Function

Manufacturing Assembly

Job Category

Business Enablement/Support

All Job Posting Locations

San Jose, California, United States of America

Job Description

Auris Health, Inc., is a member of the Johnson & Johnson Family of Companies, is recruiting for a(n) Manufacturing Lead II, located in San Jose, CA United States of America.

The I&A Manufacturing Lead II oversees daily operations of pilot and production manufacturing lines, including instruments, catheter assembly, packaging, and sterilization activities. This role manages a team of operators and technicians to meet daily build goals, ensure product quality and regulatory compliance, support new product introductions, and drive continuous improvement across manufacturing processes. The I&A Manufacturing Lead II operates in a regulated, clean-room environment and serves as a key liaison among Operations, Planning, Materials, Engineering, and Quality.

Key Responsibilities

Leads daily production readiness reviews and facilitate Tier 1/Tier 2 production meetings; communicate production status, inventory readiness, operational risks, and actions to team members.
Plan and lead daily line schedules to meet production targets; track and report hourly productivity and quality metrics.
Support work order issuance and closure, including SAP transactions, while ensuring accurate tracking, data integrity, and timely completion of daily production activities.
Train staff on processes, work instructions, equipment operation (e.g., pouch sealer, label printer, power pallet jack), environmental controls, and GMP/QSR practices.
Be responsible for production activities: assemble complex catheter devices and instruments, support fixturing and manufacturability reviews, and implement process improvement.
Support packaging and sterilization operations: stage product/materials, operate sterilization equipment and computer systems, review run records and storage requirements, and recognize/respond to abnormal sterilization conditions.
Support New Product Introduction (NPI) and Design for Manufacturability (DFM): collaborate with R&D and engineering to evaluate designs, support process/equipment qualification, and transition designs to manufacturing.
Complete troubleshooting and failure investigation: initiate and participate in multi‑functional investigations, generate investigation reports, identify corrective actions, and initiate Q‑Notes/NCRs as needed.
Ensure accurate and timely documentation:
Lot History Records, Device History Records, work instructions, test records, and work order closure. Redline or create procedures electronically.
Maintain environmental and equipment controls: record daily pressure differentials, temperature/humidity, freezer/refrigerator readings; perform weekly chart recorder changes.
Ensure…