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 revisionsTechnical 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 skillsPreferred 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 systemsWhy 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

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