I&A Manufacturing Lead II

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 interact optimally 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.
• Ability to perform other task 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.]

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Assembly Operations, Communication, Data Savvy, Execution Focus, Good Manufacturing Practices (GMP), Manufacturing Processes, Manufacturing Science and Technology (MSAT), Plant Operations, Predictive Analytics, Predictive Maintenance, Problem Solving, Process Oriented, Quality Auditing, Repair Management, Safety-Oriented, Technologically Savvy

 

 

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