Senior Design Engineer (Medical Device)

We are seeking experienced CAD Mechanical Engineers with strong expertise in SolidWorks , plastic component design , and medical device engineering . This role involves detailed CAD modeling, design validation, and troubleshooting across a wide range of medical device components, supporting the full lifecycle of product development—from concept to production and post-market support.

Key Responsibilities:

• Design and develop plastic molded components and assemblies using SolidWorks CAD tools
• Perform DFMEA , DFM , DFA , and tolerance stack-up analysis to ensure robust and manufacturable designs
• Troubleshoot and modify CAD parts with a focus on assembly impact , tool stack-up , and design optimization
• Create and manage BOMs , engineering drawings , and design documentation
• Conduct mold flow analysis and support tooling development for plastic parts
• Collaborate with cross-functional teams including R&D, manufacturing, quality, and regulatory
• Ensure compliance with ISO 13485 , FDA , and other medical device standards
• Use PLM/PDM systems for version control and design traceability
• Participate in design reviews , prototype builds , and verification testing
• Support change management and impact analysis for CAD part revisions

Technical Skills Required:

• Strong proficiency in SolidWorks for 3D modeling, assemblies, and CAD troubleshooting
• Expertise in plastic component design , mold flow analysis , and tool stack-up
• Deep understanding of GD&T , tolerance stack-up , and design calculations
• Experience with DFMEA , DFM , DFA , and BOM creation
• Familiarity with PLM/PDM tools (e.g., Windchill, SolidWorks PDM)
• Knowledge of manufacturing processes for medical-grade plastics and assemblies
• Proficient in MS Office (Word, Excel, PowerPoint)
• Strong documentation and communication skills

Preferred Qualifications:

• BE/B.Tech in Mechanical Engineering
• 5+ years of experience in medical devices or regulated industries
• Exposure to ISO 13485 , IEC 60601 , and GMP standards
• Experience in design controls , fixture design , and electromechanical systems

Why Join Us?

• Work on life-saving medical technologies that make a global impact
• Be part of a collaborative, innovative, and quality-driven team
• Opportunity to grow in a regulated, high-impact industry
• Competitive compensation, benefits, and career development support