Supply Chain Engineering

Process Engineering

People Leader

Santa Clara, California, United States of America

Johnson & Johnson RAD (Robotics and Digital) is seeking for a Operations Process Engineering Manager – OTTAVA, for our Santa Clara, Location.

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/ (https://www.jnj.com/.

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

The Operations Process Engineering Manager is accountable for establishing and leading the OTTAVA Operations Process Engineering function for regulated medical capital equipment manufacturing. The manager translates product and business requirements into capable, controlled, scalable manufacturing processes and leads the team responsible for process ownership, production support, process validation, continuous improvement, and manufacturing readiness.

This foundational role requires a hands-on people leader who can create operating structure in a high-growth environment, make risk-based decisions with cross-functional partners, and convert evolving priorities into compliant, measurable, execution-ready plans.

The ideal candidate combines process-engineering rigor, mechanical and electromechanical manufacturing experience, quality-system fluency, and practical leadership needed to industrialize, sustain, and improve complex surgical robotic equipment. The role requires proactive ownership of technical risk, disciplined escalation, and rapid, evidence-based resolution of manufacturing issues.

Key Responsibilities

• Lead the Operations Process Engineering function and maintain clear ownership, governance, priorities, technical standards, and escalation paths for manufacturing processes.
• 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; establish triage, containment, escalation, recovery, and recurrence-prevention practices appropriate to product and patient risk.
• Provide technical direction and decision support 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 applicable risk assessments, PFMEAs, 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.

People Leadership

• Set clear team priorities, technical expectations, decision rights, deliverables, and measurable accountability for safety, quality, delivery, cost, compliance, and program readiness.
• Build an organization and resource plan aligned with business needs, manufacturing demand, technical risk, and budget; identify capability or capacity gaps and propose evidence-based actions.
• Assign work based on capability, development needs, program risk, and workload, and monitor progress through structured operating reviews and visible metrics.
• Coach engineers through technical reviews, production support, investigations, validation, and cross-functional decisions while maintaining clear individual ownership.
• Provide timely, specific feedback; document performance expectations; recognize results; address performance gaps; and follow through on development commitments.
• Build team capability through hiring, onboarding, qualification, targeted training, mentoring, succession planning, and progressively complex assignments.
• Maintain role-based training and competency expectations for work performed under the quality system and ensure the team follows applicable procedures and documentation practices.
• Create an environment of constructive technical debate, objective evidence, professional resolution of disagreements, timely decision making, and transparent escalation.

Required

• Bachelor’s degree in mechanical, manufacturing, industrial, systems, biomedical, mechatronics, or another engineering discipline relevant to the role.
• Minimum eight years of progressive experience in process engineering, manufacturing engineering, or process development for complex mechanical or electromechanical products, including at least three years leading engineers or technical teams.
• Experience in a regulated medical-device manufacturing environment and working knowledge of ISO 13485 and the FDA Quality Management System Regulation under 21 CFR Part 820.
• Demonstrated experience owning manufacturing processes across introduction or transfer, validation, scale-up, routine production, change control, and sustainment.
• Strong technical competence in assembly-process design, tooling and fixture development, tolerance application, fastening or joining methods, process characterization, production test, root-cause analysis, and production problem solving.
• Demonstrated experience with risk-based process controls, including PFMEA, control plans, critical process parameters, acceptance criteria, reaction plans, capability analysis, statistical methods, yield analysis, and corrective action.
• Experience planning or approving manufacturing process validation and equipment qualification, including IQ/OQ/PQ or equivalent lifecycle documentation, as applicable.
• Experience with nonconformance, deviation, CAPA, engineering change control, controlled manufacturing documentation, and maintaining objective quality records.
• Hands-on knowledge of manufacturing metrology, measurement instrumentation, calibration, measurement system analysis, and gage R&R.
• Experience with a product lifecycle management or document-control system and an enterprise resource planning or manufacturing system used to control materials, configurations, work instructions, and production records.
• Experience leading cross-functional engineering programs, including resource planning, schedules, budgets, risks, dependencies, technical deliverables, and launch-readiness reviews.
• Demonstrated people leadership, including hiring, prioritizing work, coaching, developing technical talent, managing performance, and creating accountability.
• Ability to communicate complex technical information clearly across engineering, quality, operations, supply chain, service, and program-management functions.
• Knowledge of Lean and Six Sigma methods, structured root-cause and failure analysis, and continuous improvement.
• Ability to operate effectively through ambiguity, changing requirements, and aggressive program timelines while maintaining sound engineering and quality-system discipline.
• Ability to travel up to 10%; occasional evening or weekend support may be required during critical builds, investigations, or launches.

Preferred

• Master’s degree in engineering, engineering management, or a related technical field.
• Experience manufacturing surgical robotics, medical capital equipment, robotic systems, or other safety-critical electromechanical products.
• Experience scaling low-volume, high-complexity or high-mix capital equipment from prototype through commercial production and sustainment.
• Experience applying product and process risk-management outputs to manufacturing controls and changes, including familiarity with ISO 14971.
• Experience with computerized manufacturing systems, electronic production records, equipment software, data integrity, serial-number traceability, or manufacturing cybersecurity controls, as applicable.
• Working knowledge of mechanical CAD, geometric dimensioning and tolerancing, and engineering-drawing interpretation; SolidWorks experience is beneficial.
• Experience with automated assembly, machine vision, in-process sensing, torque-controlled fastening, adhesive or fluid dispensing, robotic calibration and alignment, manufacturing data systems, or automated test equipment.
• Experience with supplier or contract-manufacturer process development, technical transfer, validation, change control, and issue resolution.
• Experience supporting internal or external quality-system audits and regulatory inspections.
• Professional certification or formal training in Lean Six Sigma, project management, automation, metrology, or quality engineering.

• May require up to 10% domestic and/or international travel.
• The attendance policy required for this role is Fully Onsite

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

$118,000.00 to $179,035.50

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits