Operations Process Engineering Manager/Surgical Robotics-OTTAVA

Johnson & Johnson Innovative Medicine•Santa Clara, CA

9d•$118,000 - $179,036•Onsite

About The Position

Johnson & Johnson RAD (Robotics and Digital) is seeking an Operations Process Engineering Manager for OTTAVA in Santa Clara, California. The manager will establish and lead the Operations Process Engineering function for regulated medical capital equipment manufacturing, translating product and business requirements into capable, controlled, scalable manufacturing processes. The role leads process ownership, production support, process validation, continuous improvement, and manufacturing readiness. This is a hands-on people-leadership role in a high-growth environment. The manager will create operating structure, make risk-based decisions with cross-functional partners, and turn evolving priorities into compliant, measurable, execution-ready plans. The role calls for process-engineering rigor, mechanical and electromechanical manufacturing experience, quality-system fluency, proactive technical-risk ownership, disciplined escalation, and evidence-based resolution of manufacturing issues. The position is fully onsite. Travel may be required up to 10% domestically and/or internationally, and occasional evening or weekend support may be required during critical builds, investigations, or launches. The anticipated base pay range is $118,000 to $179,035.50.

Requirements

Bachelor’s degree in mechanical, manufacturing, industrial, systems, biomedical, mechatronics, or another engineering discipline relevant to the role.
At least 8 years of progressive experience in process engineering, manufacturing engineering, or process development for complex mechanical or electromechanical products, including at least 3 years leading engineers or technical teams.
Experience in regulated medical-device manufacturing and working knowledge of ISO 13485 and the FDA Quality Management System Regulation under 21 CFR Part 820.
Experience owning manufacturing processes through introduction or transfer, validation, scale-up, routine production, change control, and sustainment.
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.
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 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 work 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.

Nice To Haves

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.

Responsibilities

Lead the Operations Process Engineering function and establish 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 functions.
Provide timely technical support for manufacturing interruptions and establish 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 documentation of problem statements, objective evidence, root cause, containment, corrective action, effectiveness checks, and lessons learned.
Establish and maintain process controls, including 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 strategies, protocols, execution, deviations, reports, revalidation criteria, and ongoing monitoring as applicable.
Own production change management and ensure changes are 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 rigorously and on schedule.
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 processes and maintain their validated state.
Support supplier and contract-manufacturer readiness, technical transfer, process changes, issue resolution, and risk reduction with Supplier Quality and Supply Chain.
Ensure work instructions, specifications, training requirements, process records, configuration controls, and traceability controls are accurate, controlled, and usable at the point of execution.
Use production, service, installation, complaint, and field-performance inputs 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 process-engineering metrics and management reviews, including yield, defects and escapes, 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; document and appropriately escalate commitments, decisions, and risks.
Set 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 and 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 quality-system work and ensure the team follows applicable procedures and documentation practices.
Foster constructive technical debate, objective evidence, professional resolution of disagreements, timely decision making, and transparent escalation.

Benefits

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short- and long-term disability insurance
Business accident insurance
Group legal insurance
Pension plan
401(k) savings plan
Long-term incentive program
Vacation: 120 hours per calendar year
Sick time: 40 hours per calendar year; 56 hours per calendar year for employees residing in 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 a child’s birth, adoption, or foster care placement
Condolence leave: 30 days for an immediate family member and 5 days for an extended family member
Caregiver leave: 10 days
Volunteer leave: 4 days
Military spouse time off: 80 hours