Senior Industrial Engineer

Johnson & Johnson Innovative Medicine • Santa Clara, CA

3d • $109,000 - $174,800 • Onsite

About The Position

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).

Requirements

• Bachelor of Science degree in Industrial Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical field 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.

Nice To Haves

• Master’s degree in Industrial/Manufacturing Engineering or related field preferred.
• 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.
• 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.

Responsibilities

• 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.

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)
• Savings plan (401(k))

What This Job Offers

• Job Type: Full-time
• Career Level: Senior