I&A Manufacturing Technician II
About The Position
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.
Requirements
- 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.
- Proven understanding and experience with ISO 13485, QSR/21 CFR 820, GMPs, and documentation requirements for the medical device industry.
- 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 similar tools preferred.
- 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.
- Strong communication and leadership skills; ability to interact effectively with cross‑functional teams and levels of management.
- Able to perform duties in a cleanroom/production environment — standing, walking, handling, reaching; able to operate material handling equipment.
- Strong problem‑solving and root‑cause thinking.
- Effective communicator and great teammate; ability to train and mentor peers.
- Proactive, adaptable, and safety‑focused.
- Time management and ability to prioritize in a dynamic production environment.
- Ability to perform other duties and responsibilities as assigned based on business needs, operational requirements, departmental priorities, special projects, cross-functional support, process improvement initiatives, and other tasks that may fall outside the current job responsibilities.
Nice To Haves
- Training or education in Supply Chain, Manufacturing, Engineering Technology, or a related technical field.
- Experience with ERP systems (SAP) and Agile or similar tools.
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.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Consolidated retirement plan (pension) and savings plan (401(k))
- Long-term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
