Robotics Operations Process Engineering Manager

NCSL International; Santa Clara (CA); On-site; USD 118,000 - 179,000; Full time

Job summary

Johnson & Johnson RAD (Robotics and Digital) is seeking an Operations Process Engineering Manager for Santa Clara to lead the OTTAVA Capital Equipment Manufacturing processes. This leader translates product and business needs into scalable, compliant processes and guides a hands-on team across manufacturing, quality, R&D, and supply chain.

The ideal candidate applies engineering rigor, risk-based decision making, and experience in regulated medical-device manufacturing to industrialize, sustain,

Qualifications

• Bachelor's degree in engineering or related field and eight years of progressive process/manufacturing engineering experience.
• Experience in regulated medical-device manufacturing with ISO 13485 and FDA QMS understanding.
• Proven ownership of manufacturing processes across transfer, validation, scale-up, and change control.

Responsibilities

• Lead the Operations Process Engineering function and governance.
• Own end-to-end manufacturing processes in partnership with Operations, Quality, R&D, NPI, Test, Supply Chain, Service, and other applicable functions.
• Ensure timely technical support for manufacturing interruptions with triage, containment, escalation, recovery, and recurrence-prevention practices.
• Provide technical direction for complex mechanical, electromechanical, assembly, test, calibration, alignment, and manufacturing-data issues.
• Lead structured investigations and ensure complete documentation of problem statements, objective evidence, root cause, containment, corrective action, effectiveness checks, and lessons learned.
• Establish and maintain process controls using PFMEA, control plans, critical process parameters, acceptance criteria, reaction plans, statistical process control, capability analysis, yield monitoring, defect Pareto analysis, and structured problem solving.
• Plan and oversee manufacturing process validation and equipment qualification, including validation strategy, protocols, execution, deviations, reports, revalidation criteria, and continued monitoring, as applicable.
• Own production change management and ensure changes are technically justified, risk-assessed, verified or validated as applicable, approved, implemented, documented, and monitored for effectiveness.
• Ensure change controls, CAPAs, nonconformances, deviations, and related quality-system activities are completed with appropriate technical rigor and within committed timelines.
• Partner on design for manufacturability and assembly, tolerance analysis, production test strategy, design transfer, process characterization, production-readiness reviews, and acceptance of manufacturing deliverables.
• Define manufacturing equipment, tooling, fixtures, metrology, calibration, maintenance, software, data, and traceability requirements needed to control the process and maintain the validated state.
• Support supplier and contract-manufacturer process readiness, technical transfer, process changes, issue resolution, and risk reduction in coordination with Supplier Quality and Supply Chain.
• Ensure manufacturing work instructions, specifications, training requirements, process records, and configuration and traceability controls are accurate, controlled, and usable at the point of execution.
• Use production, service, installation, complaint, and field-performance inputs made available through applicable quality processes to identify manufacturing risks and improvement priorities.
• Lead capacity, cycle-time, labor, layout, ergonomic, automation, and capital-equipment improvement initiatives while protecting safety, quality, compliance, and product performance.
• Own operations process-engineering metrics and management reviews, including first-pass yield, defect and escape trends, cycle time, downtime, process capability, validation status, cost savings, cost avoidance, and readiness risks, as applicable.
• Lead improvement programs with defined scope, work breakdown structure, resources, budget, schedule, deliverables, dependencies, risks, benefits, and production-readiness criteria.
• Represent Operations Process Engineering in cross-functional governance, audits, inspections, and technical reviews, and ensure commitments, decisions, and risks are documented and escalated appropriately.

Skills

People leadership

Cross-functional collaboration

Lean Six Sigma

Root-cause analysis

Risk-based process controls

Project management

Regulated medical-device experience

Manufacturing process ownership

Change control

Documentation & quality systems

Education

Bachelor's degree in mechanical, manufacturing, industrial, systems, biomedical, mechatronics, or related engineering

Master's degree in engineering, engineering management, or related field

Tools

SolidWorks

Gage R&R / measurement systems analysis

ISO 13485 / FDA QMS knowledge

Job description

Johnson & Johnson RAD (Robotics and Digital) is seeking an Operations Process Engineering Manager for Santa Clara to lead the OTTAVA Capital Equipment Manufacturing processes. This leader translates product and business needs into scalable, compliant processes and guides a hands-on team across manufacturing, quality, R&D, and supply chain.

The ideal candidate applies engineering rigor, risk-based decision making, and experience in regulated medical-device manufacturing to industrialize, sustain,