Operations Process Engineer

Johnson & Johnson•Santa Clara, CA

2d•Onsite

About The Position

The Experienced Operations Process Engineer supports manufacturing execution for the OTTAVA Capital System production line. This hands-on, shop-floor role is the first line of technical support for manufacturing test and system integration activities, partnering with Manufacturing, Test, Quality, and NPI Engineering to maintain production continuity and product quality. The engineer supports integration of robotic subsystems into completed capital systems, troubleshooting manufacturing process and test failures, identifying root causes, and executing quality system activities. The role owns assigned system integration, assembly, and test processes, including safety, quality, delivery, production continuity, technical investigations, process controls, validation, change management, and compliance. It also leads continuous improvement and supports design transfer, production readiness, supplier process readiness, and manufacturing data reporting. The position is 100% onsite in Santa Clara, California; occasional evening or weekend support may be required during critical builds or investigations. The anticipated base pay range for this Bay Area position is $94,000 to $150,650. Eligible employees may participate in the company’s retirement and savings plans, long-term incentive program, and applicable time-off benefits. For additional general information on Company benefits, go to: https://www.careers.jnj.com/employee-benefits

Requirements

Bachelor's degree in Mechanical, Manufacturing, Industrial, Systems, Biomedical, Mechatronics, Electrical, or a related engineering discipline; alternatively, a master's degree with relevant industry experience.
At least 2 years of relevant experience in process engineering, manufacturing engineering, or test engineering for mechanical, electromechanical, or integrated hardware/software products.
Demonstrated ownership of production manufacturing processes, including troubleshooting, root cause analysis, and corrective action.
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.
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, California.
Occasional evening or weekend support may be required during critical builds or investigations.

Nice To Haves

Working knowledge of ISO 13485 and FDA 21 CFR Part 820 in a regulated manufacturing environment.
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; ability to read and debug scripts, preferably Python.
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 ability to respond urgently to production issues while maintaining quality and compliance.

Responsibilities

Own assigned system integration, assembly, and test processes, maintaining accountability for safety, quality, delivery, and production continuity.
Provide timely technical support for manufacturing interruptions; lead triage, containment, and recovery, and escalate issues based on product and patient risk.
Ensure work instructions, specifications, process records, and traceability controls are accurate, controlled, and usable at the point of execution.
Define tooling, fixture, equipment, and metrology requirements for assigned processes.
Lead structured investigations of mechanical, electromechanical, software, and system-level manufacturing and test failures.
Document problem statements, objective evidence, root causes, containment, corrective actions, 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.
Develop and maintain PFMEAs, control plans, critical process parameters, acceptance criteria, and reaction plans.
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 applicable deviations and revalidation assessments.
Own engineering change controls for assigned processes, ensuring changes are technically justified, risk assessed, verified or validated, implemented, and monitored for effectiveness.
Own CAPAs, NCRs, and deviations for assigned processes, including investigation, impact assessment, and timely completion.
Ensure manufacturing and documentation activities comply with approved procedures, ISO 13485, and FDA 21 CFR Part 820 requirements.
Support internal and external audits and inspections for assigned processes.
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 with Supplier Quality and Supply Chain.
Report process metrics, including first-pass yield, defect trends, downtime, and process capability, and communicate risks to engineering leadership.

Benefits

Company consolidated retirement plan (pension)
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year, with different stated amounts for employees residing in Colorado or Washington
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, or foster care of a child
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year
Caregiver Leave: 80 hours in a 52-week rolling period
Volunteer Leave: 32 hours per calendar year
Military Spouse Time-Off: 80 hours per calendar year