Stent Design Engineer (Vapi)

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

- Robust 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 Apply on Kit Job: kitjob.in/job/4mvqp3