Senior Design Engineer (Medical Device)
Infosyspune, maharashtra, in4 days ago
Job descriptionStrong 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 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 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
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 :
Preferred Qualifications :
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Senior Design Engineer • pune, maharashtra, in