Senior Industrial Engineer

Senior Industrial Engineer

Johnson & Johnson is recruiting for a Senior Industrial Engineer located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Purpose:

The Senior Industrial Engineer will lead and implement manufacturing systems, process improvement, capacity and layout design initiatives across NPI and sustaining operations for electro-mechanical and robotic medical device assembly. This role acts as a technical lead and change agent — partnering with Manufacturing, Design, Quality, Supply Chain, and Supplier teams to define and deploy robust, compliant, and efficient production systems. Responsibilities include process design and validation, labor/capacity modeling, value stream optimization, line balancing, cost reduction, and mentoring junior engineers. The role requires strong application of Lean and Six Sigma methods, data-driven decision making, and alignment to medical device regulatory requirements (e.g., GMP, ISO 13485).

In this role you will:

• Lead end-to-end industrial engineering activities for NPI and sustaining product lines, including process design, factory/line layout, work cell design, and production flow.
• Develop takt time, cycle time, and staffing models; create labor standards and line balancing to meet production volume and quality targets.
• Design and qualify manufacturing and test processes, fixtures, tooling, and automation concepts in collaboration with manufacturing and design engineering.
• Create and implement process characterization, design of experiments (DOE), process validation (IQ/OQ/PQ), and test method validation (TMV) protocols and reports.
• Drive continuous improvement projects (cost, quality, lead time) using Lean, Kaizen, and Six Sigma methodologies; quantify and realize cost and productivity benefits.
• Apply industrial engineering methods (time studies, motion studies, value stream mapping, simulation) to optimize throughput, ergonomics, and safety.
• Establish and monitor key manufacturing metrics (yield, OEE, throughput, scrap) and apply SPC to control and improve processes.
• Develop and maintain manufacturing documentation (work instructions, process control plans, PFMEA, ECOs, DHRs, MPIs) that meet internal and regulatory expectations.
• Coach and mentor junior industrial/manufacturing engineers; influence multi-functional teams and suppliers to deliver on schedule and quality.
• Support risk assessments and statistical analyses to inform design-for-manufacturing decisions and product launch readiness.
• Collaborate with IT/automation teams to integrate MES/ERP/PLM systems and support data collection for process improvement.

Qualifications:

Education:

• Bachelor of Science degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical field required.
• Master's degree in Industrial/Manufacturing Engineering or related field preferred.

Experience and Skills:

Required:

• 6+ years of industrial/manufacturing engineering experience in a high-mix, regulated manufacturing environment (medical device, automotive, electronics, or similar).
• Demonstrated expertise in line balancing, capacity planning, takt/cycle time analysis, work measurement, and labor standards.
• Strong experience leading process development and validation activities (IQ/OQ/PQ), DOE, and process characterization.
• Consistent record driving Lean and continuous improvement initiatives; familiarity with Kaizen, 5S, SMED.
• Proficiency in statistical methods and tools (SPC, capability analysis, hypothesis testing); experience with Minitab, JMP, or equivalent.
• Experience authoring and maintaining PFMEA, process control plans, work instructions, and manufacturing documentation.
• Ability to read and interpret engineering drawings, schematics, and BOMs.
• Strong problem-solving skills with experience in root cause analysis tools (5 Whys, Fishbone, 8D).
• Effective written and verbal communication skills; proven ability to influence multi-functional collaborators.
• Experience with CAD for basic layout and tooling concepting (e.g., SolidWorks, AutoCAD) and familiarity with manufacturing simulation tools (e.g., Arena, FlexSim) is preferred.
• Familiarity with electrical test equipment and electro-mechanical assemblies is a plus.

Preferred

• Experience in medical device quality systems and regulatory environments (21 CFR Part 820, ISO 13485, GMP).
• Six Sigma certification (Green/Black Belt) or equivalent continuous improvement certification.
• Experience integrating automation/robotics into production lines and working with control engineers.
• Experience using simulation software such as FlexSim or Simio to drive optimization and improvement initiatives
• Experience with PLM/ERP/MES systems (e.g., Oracle Agile, SAP, Siemens Opcenter) and basic data scripting (Python, SQL) to support analytics and automation.
• Prior experience mentoring engineers and leading multi-functional projects.

Other

• Ability to travel up to 15% to manufacturing and supplier sites.
• May be required to work in cleanroom/classified environments; must align with relevant protocols.

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, please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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)). 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 period 10 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: -