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.