Leads the design and development of complex medical devices from concept through to design freeze

Solves high-level engineering challenges using advanced materials knowledge, precision manufacturing methods, and data-driven decision making

Acts as a subject matter expert in catheter systems, extrusion-based assemblies, and biomaterials, influencing design direction and technical standards

Develops and executes verification and validation protocols (IQ/OQ/PQ), ensuring compliance with ISO 13485 and FDA 21 CFR Part 820

Manages cross-functional technical projects, balancing design intent, manufacturability, and regulatory requirements

Leads FMEA, risk analysis, and root cause investigations to ensure robust design and process outcomes

Provides technical mentoring and reviews for junior engineers ...