Samraaj Hullait

At Orthonika, I led key workstreams in developing a first-of-its-kind synthetic total meniscus replacement - a Class III medical device advancing toward First-in-Human (FIH) trials. My main roles included: Engineering & Prototyping – Designing high-performance components using injection moulding, textile technologies and 3D printing for rapid iteration. Project & Trial Management – Structuring comprehensive project plans, supporting in-vivo animal studies and coordinating with engineers, surgeons and study centres. Regulatory & Clinical Strategy – Developing strategy for US, UK & EU pathways and shaping FIH & RCT study designs. V&V Testing – Establishing novel test strategies under the FDA De Novo pathway, adapting ISO standards where needed. Commercial Insight – Aligning business plans and budgeting with FIH milestones to ensure clinical and commercial viability. I thrive in high-stakes, multidisciplinary environments, working closely with leading surgeons KOLs to ensure optimal clinical functionality and surgical adoption.

Experienced in leading the end-to-end design and development of reusable surgical instruments, combining technical expertise, innovative problem-solving, and cross-functional collaboration. Key responsibilities included: Design & Development: Delivered performance improvements for multiple instruments by conducting root cause analyses, engaging with surgeons, and employing advanced CAD modeling and rapid prototyping techniques. Manufacturing Integration: Collaborated with outsourced manufacturers to ensure seamless design for manufacture of components using machining, metal injection molding, and ceramic injection molding processes. Regulatory Compliance: Authored technical documentation for regulatory submissions (FDA), supported by EU MDR, ISO 14791 Risk Management, and GD&T training. Project Leadership: Coordinated cross-functional teams, managed contractors, and led design reviews, brainstorming sessions, and testing activities under tight deadlines. Technical Expertise: Proficient in SolidWorks and advanced in creating detailed models, drawings, and electro-mechanical test rigs that balance supplier capabilities, performance, and usability. Focused on delivering safe, innovative, and high-performance solutions in the medical device field.

4th year group project - Design of a handheld biopsy device by developing a small, handheld device to percutaneously remove small lesions from the breast. Individual Project - A sensory device to improve the sleep for children with Autism Spectrum Disorders. Relevant modules - Precision Engineering and Microsystems, Advanced Mechanical Engineering Design, Electromechanical System Design, Dynamic Analysis of Mechanical Systems, Fluid Mechanics for Mechanical Engineers, Finite Element Methods, Biomedical and Clinical Engineering, Innovative Process Development, Biomechanics.