Senior Design Engineer

Role & 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.

Preferred candidate profile

B.E/B.Tech - Mechanical or M.E/M.Tech - Mechanical

Hands on experience of 3- 6 years in Orthopedic device design in a Manufacturing Industry

Salary up to 6LPA