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 skilled Stent Design Engineer to 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 develop stents (self-expanding / balloon-expandable) from concept to commercialization
Perform design calculations, CAD modeling (SolidWorks/Creo), and detailed engineering drawings
Work on material selection (Nitinol, Co-Cr alloys) and understand superelastic behavior
Conduct finite element analysis (FEA) for fatigue, radial strength, and deployment performance
Collaborate with cross-functional teams (Manufacturing, QA/RA, Clinical Affairs)
Develop and execute design verification & validation (DV&V) plans
Support bench testing, fatigue testing, and simulated use testing
Ensure compliance with ISO 13485, FDA, and CE regulations
Participate in risk management activities (ISO 14971)
Support technology transfer from R&D to manufacturing
Required Skills & Competencies
Strong understanding of endovascular devices, especially neurovascular stents
Hands-on experience with Nitinol design & laser cutting processes
Proficiency in CAD tools (SolidWorks / Creo)
Experience in FEA tools (ANSYS / Abaqus)
Knowledge of catheter delivery systems & micro-scale design challenges
Familiarity with fatigue life, radial force, flexibility, and trackability optimization
Understanding of DFMEA, PFMEA, and Design Controls
Preferred Experience
Experience in flow diverters, intracranial stents, or embolic devices
Exposure to coating technologies (drug-eluting / hydrophilic coatings)
Knowledge of clinical requirements in neurovascular interventions
Experience working with global regulatory submissions (US/EU markets)
Key Success Factors
High precision engineering mindset
Strong problem-solving and analytical skills
Ability to work in a high-regulation, innovation-driven environment
Collaboration with surgeons and clinical teams for real-world insights
Why Join Us
Opportunity to work on cutting-edge technologies
Exposure to global markets and regulatory standards
Direct impact on life-saving medical innovations
Fast-paced growth aligned with organizational expansion goals
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