Senior Design Engineer (Medical Device)

We are seeking experienced CAD Mechanical Engineerswith strong expertise inSolidWorks ,plastic component design , andmedical 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 developplastic molded componentsand assemblies usingSolidWorks CAD tools PerformDFMEA ,DFM ,DFA , andtolerance stack-up analysisto ensure robust and manufacturable designs Troubleshoot and modify CAD parts with a focus onassembly impact ,tool stack-up , anddesign optimization Create and manageBOMs ,engineering drawings , anddesign documentation Conductmold flow analysisand support tooling development for plastic parts Collaborate with cross-functional teams including R&D, manufacturing, quality, and regulatory Ensure compliance withISO 13485 ,FDA , and other medical device standards UsePLM/PDM systemsfor version control and design traceability Participate indesign reviews ,prototype builds , andverification testing Support change management and impact analysis for CAD part revisionsTechnical Skills Required: Strong proficiency inSolidWorksfor 3D modeling, assemblies, and CAD troubleshooting Expertise inplastic component design ,mold flow analysis , andtool stack-up Deep understanding ofGD&T ,tolerance stack-up , anddesign calculations Experience withDFMEA ,DFM ,DFA , andBOM creation Familiarity withPLM/PDM tools(e.g., Windchill, SolidWorks PDM) Knowledge ofmanufacturing processesfor medical-grade plastics and assemblies Proficient inMS Office(Word, Excel, PowerPoint) Strong documentation and communication skillsPreferred Qualifications: BE/B.Tech in Mechanical Engineering 5+ years of experience inmedical devicesor regulated industries Exposure toISO 13485 ,IEC 60601 , andGMP standards Experience indesign controls ,fixture design , andelectromechanical systemsWhy Join Us? Work onlife-saving medical technologiesthat make a global impact Be part of acollaborative, innovative, and quality-driven team Opportunity to grow in aregulated, high-impact industry Competitive compensation, benefits, and career development support

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