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Develops, improves, validates, and supports manufacturing processes and equipment for regulated medical devices. Responsibilities include process control plans, equipment specification and implementation, troubleshooting, root cause analysis, corrective actions, continuous improvement, risk analysis, measurement systems analysis, validation, documentation, tooling support, and production technician guidance. The role works onsite in a cleanroom for approximately 80% of the shift and ensures compliance with safety, quality, and regulatory requirements.

Manages cross-functional engineering projects supporting medical device product development, design enhancements, and manufacturing improvements. Responsibilities include planning, scheduling, coordinating technical work, controlling scope, budgets, timelines, and deliverables, communicating project status, leading review meetings, maintaining regulatory-compliant records, resolving technical issues, and guiding project teams. Senior levels also manage complex programs, mentor project managers, and coordinate resources across functional leaders.

Design and improve minimally invasive surgical instruments and components, owning form, fit, function, and feel. Lead complex designs, design reviews, FMEA, tolerance stack-ups, failure analysis, manufacturability improvements, CAD documentation, testing, and validation support. Collaborate with Product Engineering, Manufacturing, and Operations, while providing technical leadership and mentorship on major projects. Apply FEA, GD&T, robust design, DOE, statistical analysis, and FDA/ISO standards to develop safe, reliable medical devices.

Configure and maintain product data in the EIQ ERP system, including BOMs, item masters, device master records, engineering BOMs, and work orders. Track engineering changes, reworks, deviations, and work orders while ensuring data accuracy and resolving discrepancies. Configuration Analyst II responsibilities additionally include maintaining workflows, supporting ERP enhancement projects, coordinating configuration information, and training staff. The role collaborates with Engineering, Planning, Production, customers, and ERP Systems teams.

Manages cross-functional engineering projects involving new product and systems development, design enhancements, and manufacturing improvements. Establishes scope, schedules, budgets, deliverables, and project records; leads project meetings and phase-gate reviews; communicates status and resolves technical obstacles. Senior levels independently manage complex programs, coordinate functional leaders, escalate issues, develop project-management tools, and mentor project personnel. Work must comply with medical-device quality and regulatory standards.