Develops and improves manufacturing processes, equipment, tooling, and production methods for medical devices. Responsibilities include process control planning, equipment procurement and validation, troubleshooting, root cause analysis, corrective actions, continuous improvement, risk analysis, test method validation, documentation, and regulatory compliance. The role supports production teams, manages multiple projects, prioritizes technician work, and ensures safe, efficient, high-quality manufacturing operations in a cleanroom environment.

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.

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.