Stent Design Engineer

Job Title: Stent Design Engineer Location:Vapi, Gujarat Department:R&D Experience:3–8 Years Education:B.E./B.Tech / M.E./M.Tech (Mechanical / Biomedical / Materials Science) Role Overview We are looking for a highly skilledStent Design Engineerto lead the design and development of next-generation implants. The role involves working on intricate, high-precision stent systems for treating complex cerebrovascular conditions, ensuring safety, performance, and regulatory compliance. Key Responsibilities Design and developstents(self-expanding / balloon-expandable) from concept to commercialization Performdesign calculations, CAD modeling (SolidWorks/Creo) , and detailed engineering drawings Work onmaterial selection(Nitinol, Co-Cr alloys) and understand superelastic behavior Conductfinite element analysis (FEA)for fatigue, radial strength, and deployment performance Collaborate with cross-functional teams (Manufacturing, QA/RA, Clinical Affairs) Develop and executedesign verification & validation (DV&V)plans Supportbench testing, fatigue testing, and simulated use testing Ensure compliance withISO 13485, FDA, and CE regulations Participate inrisk management activities (ISO 14971) Supporttechnology transferfrom R&D to manufacturing Required Skills & Competencies Strong understanding ofendovascular devices , especially neurovascular stents Hands-on experience withNitinol design & laser cutting processes Proficiency inCAD tools (SolidWorks / Creo) Experience inFEA tools (ANSYS / Abaqus) Knowledge ofcatheter delivery systems & micro-scale design challenges Familiarity withfatigue life, radial force, flexibility, and trackability optimization Understanding ofDFMEA, PFMEA, and Design Controls Preferred Experience Experience inflow diverters, intracranial stents, or embolic devices Exposure tocoating technologies (drug-eluting / hydrophilic coatings) Knowledge ofclinical requirements in neurovascular interventions Experience working withglobal regulatory submissions (US/EU markets) Key Success Factors High precision engineering mindset Strong problem-solving and analytical skills Ability to work in ahigh-regulation, innovation-driven environment Collaboration with surgeons and clinical teams for real-world insights Why Join Us Opportunity to work oncutting-edge technologies Exposure toglobal markets and regulatory standards Direct impact onlife-saving medical innovations Fast-paced growth aligned with organizational expansion goals

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