Manufacturing Equipment Design Engineer
6267-Auris Health Inc. Legal Entity
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Job summary
Johnson & Johnson is seeking a Manufacturing Equipment Design Engineer in Santa Clara to lead the design, development, and deployment of advanced manufacturing equipment and automation systems for robotic medical devices. You will collaborate with R&D, Operations, Quality, and Suppliers to deliver scalable, compliant solutions.
The role requires a strong background in mechanical and automation engineering, 5+ years in manufacturing engineering, and experience with IQ/OQ/PQ validation in
Qualifications
- Bachelor's degree in mechanical/manufacturing/robotics or related field.
- 5+ years in manufacturing engineering or related roles.
- Experience designing automated manufacturing equipment in regulated environments.
- Experience supporting NPI manufacturing scale‑up and production transfer.
- Supplier management, technical reviews, and equipment sourcing experience.
- Knowledge of risk management, process validation, equipment qualification, and quality system requirements.
- Strong project leadership and cross‑functional collaboration skills.
Responsibilities
- Lead design, development, and deployment of automated manufacturing equipment and test systems.
- Drive readiness activities for New Product Introduction (NPI) programs and transfers.
- Develop equipment requirements, system architectures, and acceptance criteria.
- Design automated assembly, calibration, inspection, and testing solutions to improve quality and throughput.
- Lead IQ/OQ/PQ validation and commissioning in line with regulatory requirements.
- Collaborate with product development to improve manufacturability and scalability.
- Manage supplier relationships and involvement of contract manufacturers.
- Drive capacity expansion, line transfer, and manufacturing scale‑up initiatives.
- Develop and implement equipment reliability and maintenance strategies.
- Utilize data analytics to identify process improvements and optimize performance.
- Lead root cause investigations and implement corrective actions.
- Champion lean manufacturing and six sigma initiatives.
Skills
Education
Tools
Job description
About MedTech 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. Learn more at https://www.jnj.com/medtech
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Manufacturing Equipment Design Engineer.
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.
- 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.
- Required 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.
- 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.
- Mechanical & Automation Engineering
- Precision mechanical design
- Automation systems development
- Robotic assembly systems
- Motion control systems
- Pneumatic and electromechanical systems
- Fixture and tooling design
- Machine vision integration
- Sensor and instrumentation systems
- Manufacturing Test Systems
- Functional test system development
- End‑of‑line test automation
- Calibration systems
- Data acquisition systems
- Measurement system analysis (MSA)
- Test method validation
- Software, Controls & Data Analytics
- 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
- CAD & Engineering Tools
- SolidWorks Creo AutoCAD CATIA (preferred)
- Teamcenter or equivalent PLM systems
- GD&T and tolerance stack‑up analysis
- FEA and engineering simulation tools
- Manufacturing Excellence
- 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
- Quality & Regulatory
- FDA Quality System Regulation (21 CFR Part 820)
- ISO 13485
- ISO 14971
- GMP CAPA Change Control Equipment Validation (IQ/OQ/PQ) Design Controls
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.
- Accelerating
- Analytical Reasoning
- Coaching
- Communication
- Facility Management
- Good Manufacturing Practices (GMP)
- Lean Manufacturing Principles
- Lean Supply Chain Management
- Manufacturing Engineering
- Manufacturing Science and Technology (MSAT)
- Problem Management
- Project Engineering
- Project Schedule
- Report Writing
- Safety‑Oriented
- Science
- Technology
- Engineering
- and Math (STEM) Application
- Technologically Savvy
The anticipated base pay range for this position is : $91,000.00 - $147,200.00
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 period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
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