I&A Manufacturing Lead II

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at  https://www.jnj.com./

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 housekeeping, safety, and cleanroom standards are met; stay in sync with environmental and permit/regulatory requirements. • Support continuous improvement efforts (Lean/EPS principles): identify and implement opportunities for quality, cycle time, safety, and cost improvements. • Connect with Quality, Microbiology, and other functional partners on product integrity, process deviations, and blocking issues. • Perform hands‑on work as required to meet production demand and support off‑shift coverage where vital.

Qualifications Education: • High school diploma or equivalent experience. Preferred qualifications include training or education in Supply Chain, Manufacturing, Engineering Technology, or a related technical field.

Experience and Skills: Required: • Minimum 4 years in Medical Device Manufacturing, Sterilization, or related regulated manufacturing environment.

• Regulatory/Quality: Solid understanding and experience with ISO 13485, QSR/21 CFR 820, GMPs, and documentation requirements for the medical device industry • Previous experience managing a team, coordinating the work of others, or serving in a group lead capacity is strongly preferred. • Technical skills: Shown experience with catheter or instrument assembly processes, packaging/sterilization processes, and production equipment operation. Proficient with Microsoft Office (Excel, Word, Outlook); experience with ERP systems (SAP) and Agile or similar tools preferred. • Operational skills: Able to complete test protocols, document results, perform basic failure analysis, and support process qualification activities. Able to read and follow SOPs and create/redline procedures electronically. • Interpersonal: Strong communication and leadership skills; ability to i

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