Operations Process Engineer

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 Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

About MedTech Surgery

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

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Operations Process Engineer

The Experienced Operations Process Engineer supports manufacturing execution for the OTTAVA Capital System production line. This hands-on, shop-floor role serves as the first line of technical support for manufacturing test and system integration activities. The engineer will partner with Manufacturing, Test, Quality, and NPI Engineering to maintain production continuity and product quality. The role supports integration of robotic subsystems into completed capital systems, troubleshooting of manufacturing process and test failures, root cause identification, and quality system execution.

You will be responsible for:

Process Ownership and Production Support

• •Serve as the process owner for assigned system integration, assembly, and test processes, maintaining accountability for safety, quality, delivery, and production continuity.
• •Provide timely technical support for manufacturing interruptions, leading triage, containment, and recovery, and escalating issues based on product and patient risk.
• •Ensure manufacturing work instructions, specifications, process records, and traceability controls for assigned processes are accurate, controlled, and usable at the point of execution.
• •Define tooling, fixture, equipment, and metrology requirements needed to control assigned processes.

Technical Investigations and Root Cause Analysis

• •Lead structured investigations of complex mechanical, electromechanical, software, and system-level manufacturing and test failures.
• •Document problem statements, objective evidence, root cause, containment, corrective action, and effectiveness checks.
• •Analyze manufacturing and test data to identify recurring failure modes, and drive permanent corrective actions with Test, NPI Engineering, Quality, and R&D.
• •Capture technical knowledge and lessons learned to improve troubleshooting consistency and reduce production downtime.

Process Control, Validation, and Change Management

• •Develop and maintain PFMEAs, control plans, critical process parameters, acceptance criteria, and reaction plans for assigned processes.
• •Monitor process performance using statistical process control, capability analysis, yield monitoring, and defect Pareto analysis.
• •Author and execute process validation and equipment qualification protocols and reports (IQ/OQ/PQ), including deviations and revalidation assessments, as applicable.
• •Own engineering change controls for assigned processes, ensuring changes are technically justified, risk assessed, verified or validated, implemented, and monitored for effectiveness.

Quality and Compliance

• •Own CAPAs, NCRs, and deviations for assigned processes, including investigation, impact assessment, and completion within committed timelines.
• •Ensure manufacturing and documentation activities follow approved procedures, ISO 13485, and FDA 21 CFR Part 820 requirements.
• •Support internal and external audits and inspections for assigned processes.

Continuous Improvement and Manufacturing Readiness

• •Lead improvement projects for yield, cycle time, capacity, layout, ergonomics, and cost, with defined scope, schedule, deliverables, and measurable benefits.
• •Partner with NPI and R&D on design for manufacturability and assembly, design transfer, process characterization, and production-readiness reviews.
• •Support supplier process readiness and issue resolution in coordination with Supplier Quality and Supply Chain.
• •Report process metrics such as first-pass yield, defect trends, downtime, and process capability, and communicate risks to engineering leadership.

Qualifications / Requirements:

• •Bachelor's degree in Mechanical, Manufacturing, Industrial, Systems, Biomedical, Mechatronics, Electrical, or a related engineering discipline.
• •Minimum of 2 years of relevant experience in process engineering, manufacturing engineering, or test engineering for mechanical, electromechanical, or integrated hardware/software products; or a Master's degree with relevant industry experience.
• •Demonstrated ownership of manufacturing processes in production, including troubleshooting, root cause analysis, and corrective action.
• •Experience in a regulated manufacturing environment, with working knowledge of ISO 13485 and FDA 21 CFR Part 820 preferred.
• •Hands-on experience with change control, CAPAs, NCRs, deviations, and controlled manufacturing documentation.
• •Working knowledge of PFMEA, control plans, statistical methods, process capability, and yield analysis.
• •Experience authoring or executing process validation or equipment qualification (IQ/OQ/PQ) protocols and reports.
• •Ability to interpret test results and systematically troubleshoot hardware, software, and system-level failures; ability to read and debug scripts, preferably Python.
• •Strong analytical, technical writing, and communication skills, with the ability to influence cross-functional partners without direct authority.
• •Ability to work 100% onsite in Santa Clara, CA; occasional evening or weekend support may be required during critical builds or investigations.

Preferred Qualifications:

• •Experience manufacturing surgical robotics, medical capital equipment, robotic systems, or other safety-critical electromechanical products.
• •Experience supporting design transfer or scale-up from prototype through commercial production.
• •Familiarity with ISO 14971 and applying risk-management outputs to manufacturing controls and changes.
• •Experience with Python, LabVIEW, MATLAB, SQL, automated test equipment, data acquisition tools, or manufacturing data analysis.
• •Knowledge of metrology, measurement system analysis, and gage R&R.
• •Working knowledge of mechanical CAD, GD&T, and engineering drawing interpretation; SolidWorks experience is beneficial.
• •Experience with PLM/document-control and ERP or manufacturing execution systems.
• •Lean or Six Sigma training or certification (Green Belt or equivalent).
• •A hands-on, ownership-oriented approach and the ability to respond with urgency to production issues whi