Operations Process Engineering Manager/Surgical Robotics-OTTAVA

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.

• ◆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

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 coo