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:

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 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 interact effectively with cross-functional teams and levels of management.
• Physical: 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.

Other:

• Monday-Friday, 6:00 AM to 2:30 PM, minimum 40 hours per week (onsite). Occasional evenings, weekend work, and overtime may be required.
• Physical demands: Periodic standing, sitting, or light positioning during training and work activities. Must be able to talk, hear, stand, walk, use hands/fingers, and reach with hands and arms as required by job tasks.
• Work environment: Onsite, cleanroom environments for catheter assembly and manufacturing; must follow cleanroom etiquette and GMP.
• This role requires strict adherence to traceability, documentation, and record-keeping practices.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

Required Skills:

Preferred Skills:
Agile Manufacturing, Chemistry, Manufacturing, and Control (CMC), Communication, Data Gathering and Analysis, Detail-Oriented, Document Management, Goal Attainment, Good Manufacturing Practices (GMP), Health, Safety, and Environmental (HSE) Management, Issue Escalation, Plant Operations, Problem Solving, Process Control, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Report Writing, Time Management

The anticipated base pay range for this position is :
$69,000.00 - $111,090.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits