Manufacturing Equipment Design Engineer

Johnson & Johnson • Santa Clara, CA

4d • Onsite

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/medtech. The Mechanical Manufacturing Equipment & Systems Design and Development Engineering Manager will lead the design, development, qualification, and deployment of advanced manufacturing equipment, automation systems, and test platforms supporting robotic medical device manufacturing. This role partners closely with R&D, Operations, Quality, Supply Chain, and external suppliers to deliver scalable, reliable, and compliant manufacturing solutions.

Requirements

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Robotics Engineering, Mechatronics Engineering, or related engineering discipline.
• Minimum 5 years of experience in manufacturing engineering, equipment development, automation engineering, or related technical roles.
• Experience designing and deploying automated manufacturing equipment and test systems in a regulated manufacturing environment.
• Experience supporting NPI, manufacturing scale-up, and production transfer activities.
• Demonstrated experience with supplier management, technical reviews, and equipment sourcing.
• Knowledge of risk management, process validation, equipment qualification, and quality system requirements.
• Strong project leadership and cross-functional collaboration skills.

Nice To Haves

• Advanced degree in Mechanical Engineering, Robotics, Manufacturing Engineering, or related discipline.
• Experience in robotic surgery, medical devices, electromechanical systems, or highly automated manufacturing environments.
• Lean Six Sigma Green Belt, Black Belt, PMP, or equivalent certification.
• Experience with Industry 4.0, digital manufacturing, and smart factory technologies.
• Python for automation, scripting, test development, data analytics, and process optimization
• MATLAB
• LabVIEW
• PLC programming (Allen-Bradley, Siemens, Beckhoff, or equivalent)
• HMI/SCADA systems
• SQL and manufacturing databases
• Statistical analysis tools (Minitab, JMP)
• Industrial communication protocols (EtherNet/IP, Profinet, Modbus, OPC-UA)
• MES and manufacturing data systems
• SolidWorks
• Creo
• AutoCAD
• CATIA (preferred)
• Teamcenter or equivalent PLM systems
• GD&T and tolerance stack-up analysis
• FEA and engineering simulation tools
• Design for Manufacturing (DFM)
• Design for Assembly (DFA)
• Design for Automation (DFAut)
• Design for Test (DFT)
• SPC and Process Capability Analysis
• DOE
• PFMEA and Risk Analysis
• Lean Manufacturing
• Six Sigma
• Root Cause Analysis
• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485
• ISO 14971
• GMP
• CAPA
• Change Control
• Equipment Validation (IQ/OQ/PQ)
• Design Controls

Responsibilities

• Lead the design, development, and implementation of manufacturing equipment, automation systems, tooling, fixtures, and test solutions for robotic medical devices.
• Drive manufacturing readiness activities for New Product Introduction (NPI) programs, ensuring successful transfer from development through commercialization.
• Develop equipment requirements, system architectures, functional specifications, and acceptance criteria.
• Design and implement automated assembly, calibration, inspection, and testing solutions to improve quality, throughput, and manufacturing efficiency.
• Lead equipment verification, validation, qualification (IQ/OQ/PQ), and commissioning activities in compliance with applicable regulatory and quality requirements.
• Partner with product development teams to improve manufacturability, testability, reliability, and scalability of new products.
• Manage technical relationships with equipment suppliers, automation integrators, and contract manufacturers.
• Drive capacity expansion, production ramp, line transfer, and manufacturing scale-up initiatives.
• Develop and implement equipment reliability strategies, predictive maintenance programs, and lifecycle management plans.
• Utilize data analytics and statistical methods to identify process improvement opportunities and optimize manufacturing performance.
• Lead root cause investigations and corrective actions for equipment and process-related issues.
• Champion continuous improvement initiatives focused on yield, cycle time, quality, OEE, cost reduction, and operational excellence.

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

What This Job Offers

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