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