Operations Process Engineering Manager/Surgical Robotics-OTTAVA

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.