I&A Manufacturing Technician 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 Process Improvement

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) I&A Manufacturing Technician II, located in San Jose, CA United States of America, is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science. Auris Health is building a technology platform capable of growing the applicability of robotics to a spectrum of medical procedures within our Robotics and Digital Solutions (RADS) organization.

The I&A Manufacturing Technician II position into a more technically autonomous, improvement‑focused role that provides hands‑on manufacturing execution plus technical ownership and cross‑functional support. The Internal Manufacturing professional performs complex assembly and packaging tasks, supports New Product Introduction (NPI) and process qualifications, coaches operators, leads troubleshooting and first‑line failure analysis, and helps drive continuous improvement while ensuring regulatory and quality compliance in a cleanroom/production environment. The I&A Manufacturing Technician II operates in a regulated, clean-room environment and serves as a key liaison among Operations, Planning, Materials, Engineering, and Quality.

Key Responsibilities: • Support daily production readiness reviews of Tier 1 & Tier 2 production meetings; communicate production status (as needed), inventory readiness, operational risks, and actions to stakeholders. • Serve as first line technical escalation for operators: diagnose common assembly issues, perform basic failure analysis, recommend immediate containment steps, and escalate complex issues to engineering or quality. • Maintain daily line schedules to meet production targets; track and report hourly productivity and quality metrics. • Complete daily build goals, meet yield and productivity targets, and support on‑time completion of Lot History Records (LHRs) and Device History Records (DHRs) • Train staff on processes, work instructions, equipment operation (e.g., pouch sealer, label printer, power pallet jack), environmental controls, and GMP/QSR practices. • Support production activities: assemble complex catheter devices and instruments, support fixturing and manufacturability reviews, and implement process improvement. • 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. • 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 critical 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 required. 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 • Strong technical line technician with extensive hands-on manufacturing experience and strong catheter troubleshooting skills. • Regulatory/Quality: Proven understanding and experience with ISO 13485, QSR/21 CFR 820, GMPs, and documentation requirements for the medical device industry. • Technical skills: Proven 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 simi

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