Sr. Design Engineer

Key Responsibilities: 
1. Design & Product Development 
Lead the design and development of new products and improvements to existing devices 
using SolidWorks and AutoCAD. 
Translate clinical and market requirements into functional designs while ensuring 
manufacturability and cost-effectiveness. 
Validate engineering calculations, tolerance stack-ups, and material selection for 
implantable devices and surgical instruments. 
2. Project Leadership 
Plan and execute design activities in alignment with project timelines. 
Coordinate design reviews, risk analysis, and design verification/validation. 
Collaborate with the D&D Head to define design strategy and resource allocation. 
3. Mentorship & Team Development 
Guide and mentor Junior Design Engineers in modeling, drafting, design analysis, and 
documentation. 
Review work submitted by junior staff and provide constructive feedback. 
4. Manufacturing Integration 
Ensure designs are optimized for manufacturing processes such as CNC machining, laser 
marking, anodizing, and PEEK/titanium-specific considerations. 
Work closely with production, quality, and supply chain teams to ensure smooth handover 
from design to production. 
5. Regulatory & Documentation 
Prepare and review Design History Files (DHF), Technical Files, Risk Management Reports, 
and Engineering Change Requests (ECRs). 
Ensure all designs and documentation meet CE MDR, US FDA, and CDSCO regulatory 
requirements. 
Support audits and regulatory submissions with accurate and complete documentation. 
6. Design Evaluation & Predicate Comparison 
Conduct design benchmarking and engineering justification reports. 
Compare new designs against predicate or competitive devices for clinical and functional 
performance. 
7. Innovation & Continuous Improvement 
Research new design trends, technologies, and surgical techniques in arthroscopy and 
orthopedics. 
Contribute to IP development, design patents, and publications where applicable.